Medtech regulation: FDA releases January 2014 510(k) decisions

Aug 22, 2023

February 10, 2014 By MassDevice staff

TOTAL 510(k)s THIS PERIOD 229 TOTAL WITH SUMMARIES 215 TOTAL WITH STATEMENTS 14

DEVICE: ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELELITECH GROUP 510(k) NO: K132399(TRADITIONAL)ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR S.E., SUITE 150 SE DECISION MADE: 03-JAN-14BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER BECKMAN COULTER, INC 510(k) NO: K130122(TRADITIONAL) ATTN: AMANDA BROWN PHONE NO : 714 961 6484 250 S. KRAEMER BLVD E1.SE. 01 SE DECISION MADE: 07-JAN-14 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) NANOSPHERE, INC 510(k) NO: K132843(TRADITIONAL) ATTN: MARK DEL VECCHIO PHONE NO : 847 400 9000 4088 COMMERCIAL AVENUE SE DECISION MADE: 08-JAN-14 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTEP S10 HCG SERUM/URINE COMBO TEST POLYMED THERAPEUTICS, INC 510(k) NO: K132834(TRADITIONAL) ATTN: J.J XIA PHONE NO : 301 250 0831 12828 DOE LANE SE DECISION MADE: 09-JAN-14 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT RANDOX LABORATORIES, LTD. 510(k) NO: K131554(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 289442 2413 55 DIAMOND RD. SE DECISION MADE: 09-JAN-14 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REAGENT, RUSSEL VIPER VENOM – LA CONFIRM DSRV, INC. 510(k) NO: K132076(SPECIAL) ATTN: LAWANDA WASHINGTON PHONE NO : 404 300 5121 780 PARK NORTH BLVD. SUITE 100 SE DECISION MADE: 10-JAN-14 Clarkston GA 30021 510(k) STATEMENT

DEVICE: REAGENT, RUSSEL VIPER VENOM – LA SCREEN DSRV, INC. 510(k) NO: K132130(SPECIAL) ATTN: LAWANDA WASHINGTON PHONE NO : 404 300 5121 780 PARK NORTH BLVD. SUITE 100 SE DECISION MADE: 10-JAN-14 Clarkston GA 30021 510(k) STATEMENT

DEVICE: ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD CO-INNOVATION BIOTECH CO., LTD. 510(k) NO: K131110(TRADITIONAL) ATTN: HONG FENG PHONE NO : 86 20 6287285 NO. 13 YANYUAN ROAD. TIANHE DISTRISE DECISION MADE: 15-JAN-14 GUANGZHOU, GUANGDONG CH 510507 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALPREST EUROSPITAL S.P.A. 510(k) NO: K130945(TRADITIONAL) ATTN: DAVID DUNN PHONE NO : 510 393 4216 3331 EAGLE WATCH DRIVE SE DECISION MADE: 16-JAN-14 WOODSTOCK GA 30189 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY IMMUNALYSIS CORPORATION 510(k) NO: K131168(TRADITIONAL) ATTN: JOSEPH GINETE PHONE NO : 909 482 0840 829 TOWNE CENTER DR. SE DECISION MADE: 17-JAN-14 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM SD BIOSENSOR 510(k) NO: K123517(SPECIAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SE DECISION MADE: 17-JAN-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K131307(TRADITIONAL) ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVE SE DECISION MADE: 24-JAN-14 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK BIOPHOR DIAGNOSTICS, INC. 510(k) NO: K133642(TRADITIONAL) ATTN: NATHANIEL G BUTLIN PHONE NO : 650 367 4954 1201 DOUGLAS AVE SE DECISION MADE: 24-JAN-14 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT GOLD STANDARD DIAGNOSTICS 510(k) NO: K131330(TRADITIONAL) ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000 2851 SPAFFORD SE DECISION MADE: 28-JAN-14 Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K131364(TRADITIONAL) ATTN: SHIVEN GANDHI PHONE NO : 424 218 8322 2151 E. GRAND AVE. SE DECISION MADE: 02-JAN-14 EL SEGUNDO CA 90245 5017 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMATOM DEFINITION AS OPEN SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K130901(TRADITIONAL) ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PARKWAY SE DECISION MADE: 02-JAN-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEC MODEL M15SOURCE PRODUCTION & EQUIPMENT CO.,510(k) NO: K132969(TRADITIONAL)ATTN: KELLEY RICHARDT PHONE NO : 504 464 9471 113 Teal St. SE DECISION MADE: 02-JAN-14Saint Rose LA 70087 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROFERA BLUE PU BACTERIOSTATIC DRESSING HYDROFERA, LLC. 510(k) NO: K130670(TRADITIONAL) ATTN: HEATHER S SOMERS PHONE NO : 860 456 0677 322 MAIN ST., SUITE 1101 SE DECISION MADE: 02-JAN-14 WILLIMANTIC CT 06226 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSCALPEL LIGHTSCALPEL LLC 510(k) NO: K132661(TRADITIONAL) ATTN: DAVID WALTERS PHONE NO : 425 368 1588 16932 Woodinville Redmond Rd NE StSE DECISION MADE: 02-JAN-14 Woodinville WA 98072 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K133512(TRADITIONAL) ATTN: ANNA MARIE K ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE MS 514 SE DECISION MADE: 02-JAN-14 NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GELPOINT PATH TRANSANAL ACCESS PLATFORM APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K133393(TRADITIONAL) ATTN: FRANS VANDENBROEK PHONE NO : 949 713 8369 22872 AVENIDA EMPRESA SE DECISION MADE: 02-JAN-14 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIREN EPCR SUITE MEDUSA MEDICAL TECHNOLOGIES INC. 510(k) NO: K131272(TRADITIONAL) ATTN: DIANE SUDDUTH PHONE NO : 512 327 9997 816 CONGRESS AVE. SUITE 1400 SE DECISION MADE: 03-JAN-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FMWAND FERROMAGNETIC SURGICAL SYSTEM DOMAIN SURGICAL, INC. 510(k) NO: K130606(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801 924 4950 1370 S 2100 E SE DECISION MADE: 03-JAN-14 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM SPINEFRONTIER, INC. 510(k) NO: K131880(ABBREVIATED) ATTN: MEREDITH MAY PHONE NO : 719 264 9937 4628 NORTHPARK DRIVE SE DECISION MADE: 03-JAN-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRISMAFLEX SYSTEM 7.10 GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K131516(TRADITIONAL) ATTN: KAE MILLER PHONE NO : 303 222 6724 14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 03-JAN-14 LAKEWOOD CO 80401 510(k) STATEMENT

DEVICE: BAUSCH + LUMB, VIS100 INJECTOR SYSTEM BAUSCH & LOMB 510(k) NO: K133146(SPECIAL) ATTN: SHIVANI K CHITALIA PHONE NO : 949 398 5632 50 TECHNOLOGY DRIVE SE DECISION MADE: 03-JAN-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM – DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES CONMED CORPORATION 510(k) NO: K133224(SPECIAL) ATTN: NYROBIA FREEMAN PHONE NO : 727 399 5416 11311 CONCEPT BLVD. SE DECISION MADE: 03-JAN-14 LARGO FL 33773 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUSION SINGLE LINK ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K132923(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 03-JAN-14 AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133312(SPECIAL) ATTN: YINGYING GAO PHONE NO : 508 683 4356 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 03-JAN-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOHELIX SYNDESMOSIS FIXATION DEVICESORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K132733(TRADITIONAL)ATTN: BRIAN HOCKETT PHONE NO : 330 869 9562 1065 Medina Rd. SUITE 500 SE DECISION MADE: 03-JAN-14Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133645(TRADITIONAL) ATTN: BECKY RONNER PHONE NO : 800 876 3133 1800 PYRAMID PLACE SE DECISION MADE: 03-JAN-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WAVE 2G, SOUL HANSATON AKUSTIK GMBH 510(k) NO: K130937(TRADITIONAL) ATTN: NICK BURMESTER PHONE NO : 49 406 68788128 BEIM STROHHAUSE 17 SE DECISION MADE: 03-JAN-14 HAMBURG GM 20097 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRU FLU MERIDIAN BIOSCIENCE, INC. 510(k) NO: K133714(SPECIAL) ATTN: SUSAN ROLIH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 03-JAN-14 CINCINNATI OH 45244 510(k) STATEMENT

DEVICE: SYNGO.VIA WEB VIEWER SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K130998(TRADITIONAL) ATTN: SABINE SCHROEDEL PHONE NO : 49 919184 8285 HENKESTRASSE 127 SE DECISION MADE: 03-JAN-14 ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACON ON CALL DIABETES MANAGEMENT SOFTWARE ACON LABORATORIES, INC. 510(k) NO: K131469(SPECIAL) ATTN: QIYI XIE PHONE NO : 858 875 8011 10125 Mesa Rim Road SE DECISION MADE: 06-JAN-14 SAN DIEGO CA 92121 510(k) STATEMENT

DEVICE: LATERAL SYNFIX SYNTHES (USA) PRODUCTS LLC 510(k) NO: K131276(TRADITIONAL) ATTN: MONIKA MCDOLE-RUSSELL PHONE NO : 610 719 5448 1302 WRIGHTS LANE EAST SE DECISION MADE: 06-JAN-14 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIFLUX ULTRA DIALYZER FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K123262(TRADITIONAL) ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 06-JAN-14 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED HAND PLATING SYSTEM ACUMED LLC 510(k) NO: K132769(TRADITIONAL) ATTN: MARIAH KNIGHT PHONE NO : 503 207 1530 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 06-JAN-14 HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISTALOCK TIBIAL IM NAIL SYSTEM DGIMED ORTHO, INC 510(k) NO: K132830(TRADITIONAL) ATTN: SCOTT YOUNGSTROM PHONE NO : 952 582 6711 12400 WHITEWATER DRIVE, SUITE 2010SE DECISION MADE: 06-JAN-14 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER SAKURA SEIKI CO., LTD. 510(k) NO: K132439(TRADITIONAL) ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 06-JAN-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: ULTRASOUND SCANNER PRO FOCUS 2202 B-K MEDICAL APS 510(k) NO: K132685(TRADITIONAL) ATTN: GERT NIELSEN PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 06-JAN-14 HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI LED INTELLECTUAL PROPERTIES, LLC 510(k) NO: K131461(TRADITIONAL) ATTN: STEVE MARCHESE PHONE NO : 949 502 4088 16552 VON KARMAN AVE. SE DECISION MADE: 06-JAN-14 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTONEMV INCONTROL MEDICAL, LLC 510(k) NO: K133826(SPECIAL) ATTN: JESSICA ANDRESHAK PHONE NO : 262 373 0422 3225 GATEWAY ROAD, SUITE 250 SE DECISION MADE: 06-JAN-14 BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS3512 (ML21035) JVC KENWOOD CORPORATION 510(k) NO: K133686(TRADITIONAL) ATTN: TSUKASA TASHIRO PHONE NO : 81 258 6611 3-12, MORIYACHO, KANAGAWA-KU SE DECISION MADE: 06-JAN-14 YOKOHAMA-SHI, KANAGAWA JA 221-0510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS SURGICAL INSTRUMENTS SERVICE AND S510(k) NO: K124033(TRADITIONAL) ATTN: BRANDI J PANTELEON PHONE NO : 541 923 3310 2747 SW 6TH STREET SE DECISION MADE: 07-JAN-14 REDMOND OR 97756 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D-RAD SMART PACK SMITH & NEPHEW, INC. 510(k) NO: K132296(TRADITIONAL) ATTN: MARTIN OSTMANN PHONE NO : 901 399 1809 1450 BROOKS RD. SE DECISION MADE: 07-JAN-14 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANDONG BINXIANG MEDICAL PRODUCTS510(k) NO: K131832(TRADITIONAL) ATTN: RAY ZHOU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 07-JAN-14 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIA RADIAL HEAD SYSTEM IMDS (INNOVATIVE MEDICAL DEVICE SY510(k) NO: K132735(TRADITIONAL) ATTN: ANDREW RYNEARSON PHONE NO : 407 770 0258 2710 DISCOVERY DRIVE, STE 600 CO-ISE DECISION MADE: 07-JAN-14 ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE CARDICA, INC. 510(k) NO: K132581(TRADITIONAL) ATTN: FREDERICK BAUER PHONE NO : 650 331 7163 900 SAGINAW DR. SE DECISION MADE: 07-JAN-14 Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER FLEX FOCUS 1202 B-K MEDICAL APS 510(k) NO: K132677(TRADITIONAL) ATTN: GERT NIELSEN PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 07-JAN-14 HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD INTUITIVE SURGICAL, INC. 510(k) NO: K133167(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 408 523 7485 1266 KIFER RD SE DECISION MADE: 07-JAN-14 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDSS SLC BLACK DIAMOND VIDEO 510(k) NO: K133413(TRADITIONAL) ATTN: RAGUNATH MUNIANDY PHONE NO : 510 439 4500 503 CANAL BLVD. SE DECISION MADE: 07-JAN-14 RICHMOND CA 94804 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC SUTURE CUTTERUNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K133736(TRADITIONAL)ATTN: ERIC MAYNARD PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 07-JAN-14MENTOR OH 44060 510(k) STATEMENT

DEVICE: ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER BIOLITEC SIA 510(k) NO: K130681(TRADITIONAL) ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 08-JAN-14 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V-PATCH SYSTEM INTELESENS LIMITED 510(k) NO: K131000(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 08-JAN-14 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE DENTAL MORELLI 510(k) NO: K130476(TRADITIONAL) ATTN: LILIAN LLULL PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 08-JAN-14 AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE OSCOR INC. 510(k) NO: K130843(TRADITIONAL) ATTN: MILA DOSKOCIL PHONE NO : 727 937 2511 3816 Desoto Blvd SE DECISION MADE: 08-JAN-14 PALM HARBOR FL 34683 510(k) STATEMENT

DEVICE: 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS BIOMET 3I 510(k) NO: K133049(TRADITIONAL) ATTN: CHRIS MCKEE PHONE NO : 561 776 6700 4555 RIVERSIDE DRIVE SE DECISION MADE: 08-JAN-14 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE MEDICAL COMPONENTS INC 510(k) NO: K132880(TRADITIONAL) ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 08-JAN-14 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC MESH NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K132247(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001 11820 RED HIBISCUS DRIVE SE DECISION MADE: 08-JAN-14 BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM EMERGE MEDICAL 510(k) NO: K133452(TRADITIONAL) ATTN: MICHELLE POTVIN PHONE NO : 720 459 6392 720 S. COLORADO BLVD. SE DECISION MADE: 08-JAN-14 DENVER CO 80246 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCCLUDER OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133750(TRADITIONAL) ATTN: CHRISTINE SHOEMAKER PHONE NO : 508 683 4214 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 08-JAN-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO GIA(TM) EXTRA LONG ADAPTER COVIDIEN LLC 510(k) NO: K133762(SPECIAL) ATTN: DEBRA PEACOCK PHONE NO : 203 492 6935 60 MIDDLETOWN AVENUE SE DECISION MADE: 08-JAN-14 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM ENDOCHOICE, INC. 510(k) NO: K133747(SPECIAL) ATTN: DANIEL HOEFER PHONE NO : 678 708 4743 11810 WILLS ROAD SUITE 100 SE DECISION MADE: 08-JAN-14 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOPULSE/ SONOPULSE III IBRAMED- INDUSTRIA BRAZILERIA DE E510(k) NO: K130888(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 377 0077 18851 NE 29TH AVE, 720 SE DECISION MADE: 09-JAN-14 AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM STRYKER 510(k) NO: K121235(TRADITIONAL) ATTN: JAMSHED BADARPURA PHONE NO : 269 389 4260 750 TRADE CENTRE WAY STE 200 SE DECISION MADE: 09-JAN-14 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIM PROM ALERE SCARBOROUGH, INC 510(k) NO: K123986(TRADITIONAL) ATTN: ANGELA DRYSDALE PHONE NO : 207 730 5737 10 SOUTHGATE ROAD SE DECISION MADE: 09-JAN-14 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH & LOMB INJECTOR SYSTEM BAUSCH & LOMB 510(k) NO: K131958(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 800 393 6642 30 ENTERPRISE SUITE 450 SE DECISION MADE: 09-JAN-14 ALISO VIEJO CA 92656 7115 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDOS HILITE 7000 & 7000 LT OXYGENATOR MEDOS MEDIZINTECHNIK AG 510(k) NO: K133261(SPECIAL) ATTN: LEANN CHRISTMAN PHONE NO : 734 995 9098 3526 WEST LIBERTY RD. SE DECISION MADE: 09-JAN-14 ANN ARBOR MI 48103 48103 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMPAX M PLASTIC TAMPONS, UNSCENTED THE PROCTER & GAMBLE COMPANY 510(k) NO: K133244(SPECIAL) ATTN: KATHLEEN BLIESZNER, PH.D. PHONE NO : 513 634 3168 6110 CENTER HILL AVENUE SE DECISION MADE: 09-JAN-14 CINCINNATI OH 45224 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDLINE (TM) CENTINEL SPINE, INC. 510(k) NO: K133286(SPECIAL) ATTN: JOHN PARRY PHONE NO : 900 AIRPORT RD, STE #3B SE DECISION MADE: 09-JAN-14 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOLOCK BIOTECH, INC. 510(k) NO: K122982(TRADITIONAL) ATTN: ROBYN SCOPIS PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 09-JAN-14 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALAMO C ALLIANCE PARTNERS, LLC 510(k) NO: K133321(SPECIAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 930 2015 33490 PIN OAK PARKWAY SE DECISION MADE: 09-JAN-14 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISO-GARD MASK TELEFLEX MEDICAL, INC. 510(k) NO: K132729(SPECIAL) ATTN: ANGELA BOUSE PHONE NO : 919 433 4904 2917 WECK DR. SE DECISION MADE: 09-JAN-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. 510(k) NO: K133256(TRADITIONAL) ATTN: ANITA SHAH PHONE NO : 781 345 9164 28 Crosby Dr SE DECISION MADE: 09-JAN-14 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAMPART-L SPINEOLOGY, INC. 510(k) NO: K133371(SPECIAL) ATTN: BRYAN BECKER PHONE NO : 651 256 8534 7800 3RD ST NORTH SUITE 600 SE DECISION MADE: 09-JAN-14 ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMMERLOCK 2 BIOMEDICAL ENTERPRISES, INC 510(k) NO: K133520(TRADITIONAL) ATTN: JOE SOWARD PHONE NO : 210 677 0354 14785 OMICRON DR STE 205 SE DECISION MADE: 09-JAN-14 SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY HANS BIOMED CORP. 510(k) NO: K130235(TRADITIONAL) ATTN: PATSY J TRISLER, JD, RAC PHONE NO : 301 652 5344 5600 WISCONSIN AVENUE #509 SE DECISION MADE: 10-JAN-14 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJIFILM 600 SERIES ENDOSCOPES FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K132210(TRADITIONAL) ATTN: GINA WALLJASPER PHONE NO : 973 686 2636 10 HIGH POINT DR SE DECISION MADE: 10-JAN-14 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ET PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K130662(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 10-JAN-14 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANNEXTM ADJACENT LEVEL SYSTEM SPINE WAVE, INC. 510(k) NO: K132403(TRADITIONAL) ATTN: JOSEPH MERCADO PHONE NO : 203 944 9494 3 ENTERPRISE DR. SUITE 210 SE DECISION MADE: 10-JAN-14 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOACTIVE BONE GRAFT PUTTY BIOSTRUCTURES, LLC 510(k) NO: K132071(TRADITIONAL) ATTN: PATSY J TRISLER, JD, RAC PHONE NO : 301 652 5344 5600 WISCONSIN AVE. #509 SE DECISION MADE: 10-JAN-14 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER FLEX FOCUS 1202 B-K MEDICAL APS 510(k) NO: K132335(TRADITIONAL) ATTN: RANDI HAUERBERG PHONE NO : 454 45 28100 MILEPARKEN 34 SE DECISION MADE: 10-JAN-14 HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER PRO FOCUS 2202B-K MEDICAL APS 510(k) NO: K132346(TRADITIONAL)ATTN: RANDI HAUERBERG PHONE NO : 45 445281 00MILEPARKEN 34 SE DECISION MADE: 10-JAN-14HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXMAP 3D LUMINEX CORP. 510(k) NO: K133302(TRADITIONAL) ATTN: CHRISTIE HUGHES PHONE NO : 512 219 8020 12212 TECHNOLOGY BLVD. SE DECISION MADE: 10-JAN-14 AUSTIN TX 78727 6115 510(k) STATEMENT

DEVICE: AXIUM DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K133310(SPECIAL) ATTN: ANGELA LAMPREY PHONE NO : 949 297 9781 9775 TOLEDO WAY SE DECISION MADE: 10-JAN-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NERVE CUFF COOK BIOTECH INCORPORATED 510(k) NO: K132660(TRADITIONAL) ATTN: MARY A FADERAN PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 10-JAN-14 WEST LAFAYETTE IN 47906 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROBEAM PROTON THERAPY SYSTEM VARIAN MEDICAL SYSTEMS 510(k) NO: K133191(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 10-JAN-14 PALO ALTO CA 94304 1129 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGIFIX EXTERNAL FIXATION SYSTEM VIRAK ORTHOPEDIC RESEARCH, LLC 510(k) NO: K132731(TRADITIONAL) ATTN: KIMBERLY STROHKIRCH PHONE NO : 901 361 2037 3416 ROXEE RUN COVE SE DECISION MADE: 10-JAN-14 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANPAC WORD/BARTHOLIN CATHETER PANPAC MEDICAL CORPORATION 510(k) NO: K130087(TRADITIONAL) ATTN: YEN-MING PAN PHONE NO : 886 286472 242 NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 10-JAN-14 SHI-CHIH CITY, TAIPEI HSIEN TW 510(k) STATEMENT

DEVICE: ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS THE ANSPACH EFFORT, INC. 510(k) NO: K133604(SPECIAL) ATTN: JEANNETTE G DAILEY PHONE NO : 561 494 3710 4500 RIVERSIDE DR. SE DECISION MADE: 10-JAN-14 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT PULMONARY ANALYSIS QI IMAGING, LLC 510(k) NO: K130552(TRADITIONAL) ATTN: RICHARD BALL PHONE NO : 650 413 1364 1235 RADIO ROAD, STE 110 SE DECISION MADE: 13-JAN-14 REDWOOD CITY CA 94065 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE XERIDIEM MEDICAL DEVICES 510(k) NO: K130674(TRADITIONAL) ATTN: MICHELLE LOTT PHONE NO : 520 882 7794 4700 S Overland Dr SE DECISION MADE: 13-JAN-14 TUCSON AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROXIFAST ABSORBABLE STAPLE SURGIMATIX, INC. 510(k) NO: K132669(TRADITIONAL) ATTN: GRACE CARLSON, MD PHONE NO : 847 400 2546 1539 JARVIS AVE SE DECISION MADE: 13-JAN-14 ELK GROVE VILLAGE IL 60007 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S9 CRONULLA FOR HER RESMED LTD. 510(k) NO: K132606(TRADITIONAL) ATTN: PHONE NO : 9001 SPECTRUM CENTER BLVD SE DECISION MADE: 13-JAN-14 KEARNY MESA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANTIS PEDICLE SCREW SYSTEM LANTERNA MEDICAL TECHNOLOGIES 510(k) NO: K133063(TRADITIONAL) ATTN: RICH JANSEN, PHARM.D. PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 13-JAN-14 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM SPINESELECT, LLC 510(k) NO: K133066(TRADITIONAL) ATTN: RICH JANSEN, PHARM.D. PHONE NO : 612 281 5505 13540 GUILD AVE SE DECISION MADE: 13-JAN-14 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED TREVO PROVUE RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K132641(TRADITIONAL) ATTN: SARAH MEYER PHONE NO : 510 413 2681 301 E. EVELYN AVE. SE DECISION MADE: 13-JAN-14 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIXING SYRINGE SYSTEM ZIMMER KNEE CREATIONS, INC. 510(k) NO: K133021(TRADITIONAL) ATTN: SHAUN HANSON PHONE NO : 484 753 5461 841 Springdale Drive SE DECISION MADE: 13-JAN-14 Exton PA 19341 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. 510(k) NO: K130828(TRADITIONAL) ATTN: AMY MCKINNEY PHONE NO : 979 236 1622 6518 TAMARIND SKY LN. SE DECISION MADE: 13-JAN-14 FULSHEAR TX 77441 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CO2/O2 NASAL CANNULA (WITH 4" (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8" (240CM) O2 AND 4" (10CM) CO2 TUBE), SOUTHMEDIC, INC. 510(k) NO: K131410(TRADITIONAL) ATTN: TISH ANGER PHONE NO : 705 720 1902 50 ALLIANCE BLVD., SE DECISION MADE: 13-JAN-14 BARRIE, ONTARIO CA L4M 5K3 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO. 510(k) NO: K133407(SPECIAL) ATTN: CAROL MARBLE PHONE NO : 781 861 4467 180 HARTWELL ROAD SE DECISION MADE: 13-JAN-14 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRABLOX BLOXR CORPORATION 510(k) NO: K133684(TRADITIONAL) ATTN: RAI CHOWDHARY PHONE NO : 801 590 9880 960 LEVOY DRIVE SE DECISION MADE: 13-JAN-14 SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M2 WRIST 2 MRI SYSTEM ASPECT IMAGING LTD 510(k) NO: K130692(TRADITIONAL) ATTN: GEORGE HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVE. SE DECISION MADE: 14-JAN-14 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC ABSORBABLE SUTURE FOOSIN MEDICAL SUPPLIES INC.LTD 510(k) NO: K130735(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212281 5850 PO BOX 237-023 SE DECISION MADE: 14-JAN-14 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC ABSORBABLE SUTURE FOOSIN MEDICAL SUPPLIES INC.LTD 510(k) NO: K130737(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212281 850 PO BOX 120-119 SE DECISION MADE: 14-JAN-14 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COSENSE CO MONITOR CAPNIA, INC. 510(k) NO: K130036(TRADITIONAL) ATTN: JULIE BLACKLOCK PHONE NO : 650 213 8444 2445 FABER PLACE, STUITE 250 SE DECISION MADE: 14-JAN-14 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S IVOCLAR VIVADENT, INC. 510(k) NO: K132984(TRADITIONAL) ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 14-JAN-14 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K132739(ABBREVIATED) ATTN: GARO MIMARYAN PHONE NO : 914 524 3270 511 BENEDICT AVE SE DECISION MADE: 14-JAN-14 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TASMIN R SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K123758(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 14-JAN-14 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUZHOU BEINUO SURGICAL STAPLERS – CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA SUZHOU BEINUO MEDICAL EQUIPMENT CO510(k) NO: K133499(TRADITIONAL) ATTN: ROBERT SEIPLE, RAC PHONE NO : 512 327 9997 816 CONGRESS AVE., STE 1400 SE DECISION MADE: 14-JAN-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIGER SPINE SYSTEMCORELINK LLC 510(k) NO: K133369(SPECIAL)ATTN: J D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 14-JAN-14ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPHOTAS CELLUMA BIOPHOTAS, INC. 510(k) NO: K131113(TRADITIONAL) ATTN: SHEPARD G BENTLEY PHONE NO : 949 495 4274 28241 CROWN VALLEY PARKWAY, SUITE SE DECISION MADE: 15-JAN-14 LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPUTED RADIOGRAPHY SCANNER 3DISC AMERICAS 510(k) NO: K133120(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 15-JAN-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPUTED RADIOGRAPHY SCANNER 3DISC AMERICAS 510(k) NO: K133106(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 15-JAN-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT UNITED ORTHOPEDIC CORPORATION 510(k) NO: K131864(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357733 51 NO 57, PARK AVE 2, SCIENCE PARK SE DECISION MADE: 15-JAN-14 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILUMINAGE SKIN SMOOTHING LASER CYNOSURE, INC. 510(k) NO: K133473(SPECIAL) ATTN: KEVIN O’CONNELL PHONE NO : 978 367 8736 5 CARLISLE ROAD SE DECISION MADE: 15-JAN-14 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) AIDE PLASTIC CO., LTD. 510(k) NO: K130732(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 108238 7441 RM 1606 BLDG.1, JIANXIANG YUAN NO.SE DECISION MADE: 16-JAN-14 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOCENTER SATELEC-ACTEON GROUP 510(k) NO: K131151(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 856 222 9988 124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 16-JAN-14 MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOLPHIX EXTERNAL FIXATION SYSTEM CITIEFFE S.R.L. 510(k) NO: K132363(TRADITIONAL) ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630 110 E. GRANADA BLVD SUITE 209 SE DECISION MADE: 16-JAN-14 ORMOND BEACH FL 32176 510(k) STATEMENT

DEVICE: OPTIO-C ANTERIOR CERVICAL SYSTEM ZIMMER SPINE, INC. 510(k) NO: K132894(TRADITIONAL) ATTN: DONNA SEMLAK PHONE NO : 952 857 5643 7375 BUSH LAKE RD. SE DECISION MADE: 16-JAN-14 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE HEALTHCARE FINLAND OY 510(k) NO: K132528(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 358 10 39411 KUORTANEENKATU 2 SE DECISION MADE: 16-JAN-14 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKNIT MICROCOPY, DIV. OF NEO-FLO INC. 510(k) NO: K131799(TRADITIONAL) ATTN: PEGGY GOBER PHONE NO : 770 425 5715 3120 MOON STATION RD. NW SE DECISION MADE: 16-JAN-14 KENNESAW GA 30144 9017 510(k) STATEMENT

DEVICE: STARLIGHT ORTHOMERICA PRODUCTS, INC. 510(k) NO: K133250(TRADITIONAL) ATTN: DAVID L HOOPER PHONE NO : 407 290 6592 6333 NORTH ORANGE BLOSSOM TRAIL SE DECISION MADE: 16-JAN-14 ORLANDO FL 32810 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNESYS TOP-LOADING SPINAL SYSTEM ZIMMER SPINE, INC 510(k) NO: K133164(TRADITIONAL) ATTN: MICHELLE LENZ PHONE NO : 952 830 6243 7375 BUSH LAKE RD. SE DECISION MADE: 16-JAN-14 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-SWITCHED ND:YAG LASER BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131857(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 212281 5850 P.O. BOX 120-119 SE DECISION MADE: 16-JAN-14 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU ARTHROCARE CORPORATION 510(k) NO: K133727(SPECIAL) ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995 7000 West William Cannon Drive SE DECISION MADE: 16-JAN-14 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE SYSTEM SYNTHES USA PRODUCTS LLC 510(k) NO: K133698(SPECIAL) ATTN: LAURA BLEYENDAAL PHONE NO : 508 828 3267 325 PARAMOUNT DRIVE SE DECISION MADE: 16-JAN-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWERGLIDE MIDLINE CATHETER C.R. BARD, INC. 510(k) NO: K133856(SPECIAL) ATTN: CASEY COOMBS PHONE NO : 801 522 5869 605 NORTH 5600 WEST SE DECISION MADE: 16-JAN-14 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEM-7311 OMRON HEALTHCARE, INC. 510(k) NO: K133379(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 16-JAN-14 BONITA SPRINGS FL 34134 34134 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APOLLO SYSTEM PENUMBRA, INC. 510(k) NO: K132931(TRADITIONAL) ATTN: SETH SCHULMAN PHONE NO : 510 748 3223 1351 HARBOR BAY PARKWAY SE DECISION MADE: 17-JAN-14 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS LAURA CATTABRIGA 510(k) NO: K130614(TRADITIONAL) ATTN: LAURA CATTABRIGA PHONE NO : 7430 CENTER BAY DRIVE SE DECISION MADE: 17-JAN-14 N. BAY VILLAGE FL 33141 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W GE MEDICAL SYSTEMS, LLC 510(k) NO: K132410(TRADITIONAL) ATTN: HELEN PENG PHONE NO : 262 424 8222 3000 N GRANDVIEW BLVD. SE DECISION MADE: 17-JAN-14 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OREGON SCINTIFIC IDT TECHNOLOGY LIMITED 510(k) NO: K131245(TRADITIONAL) ATTN: LILY LI PHONE NO : 867 552970 1070 BLOCK 33, IDT TECHNOLOGY LIMITED, SE DECISION MADE: 17-JAN-14 SHENZHEN, CH CH 510(k) STATEMENT

DEVICE: GALAXY PLUS MEDIEN INTERNATIONAL CO., LTD 510(k) NO: K132921(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT. SE DECISION MADE: 17-JAN-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOB DISPOSABLE SPECULUM IOB MEDICAL INC 510(k) NO: K132668(TRADITIONAL) ATTN: JOE XIA PHONE NO : 301 250 0831 504E DIAMOND AVE. SUITE F SE DECISION MADE: 17-JAN-14 GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTDOP XT KOVEN TECHNOLOGY, INC. 510(k) NO: K131623(TRADITIONAL) ATTN: HARVEY KNAUSS PHONE NO : 832 675 9281 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 17-JAN-14 HOUSTON TX 77071 3404 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XARIO 100 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133277(TRADITIONAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DRIVE SE DECISION MADE: 17-JAN-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEMICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K133228(TRADITIONAL)ATTN: MARC E RUHLING PHONE NO : 574 269 4266 4130 CORRIDOR DRIVE SE DECISION MADE: 17-JAN-14WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPRAPUBIC CATHETER AND INTRODUCER SET MEDIPLUS LTD. 510(k) NO: K132890(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 UNIT 7, THE GATEWAY CENTRE CORONATSE DECISION MADE: 17-JAN-14 HIGH WYCOMBE, BUCKS UK HP12 35U510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA ATHEROMED INC 510(k) NO: K132682(TRADITIONAL) ATTN: ELISA HEBB PHONE NO : 650 473 6846 1455 ADAMS DRIVE SUITE 1110 SE DECISION MADE: 17-JAN-14 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INJECTION NEEDLE ENDOCHOICE, INC. 510(k) NO: K132065(TRADITIONAL) ATTN: THERON GOBER PHONE NO : 678 534 6021 11810 WILLS ROAD SE DECISION MADE: 17-JAN-14 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K133197(TRADITIONAL) ATTN: KENT PRUETT PHONE NO : 830 372 1391 940 Crossroads Blvd SE DECISION MADE: 17-JAN-14 Seguin TX 78155 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR BANYAN MEDICAL, LLC. 510(k) NO: K133375(TRADITIONAL) ATTN: TAMMY HEALEY PHONE NO : 401 383 9336 89 BELLOWS STREET SE DECISION MADE: 17-JAN-14 WARWICK RI 02888 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT CENTER FOR DISEASE CONTROL AND PRE510(k) NO: K133869(SPECIAL) ATTN: HYE-JOO KIM PHONE NO : 404 639 4643 1600 CLIFTON ROAD, MS-C18 SE DECISION MADE: 17-JAN-14 ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA ORTHO KINEMATICS, INC. 510(k) NO: K133875(SPECIAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 13TH STREET, NW SE DECISION MADE: 17-JAN-14 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED TREVO PROVUE RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K133464(SPECIAL) ATTN: SARAH MEYER PHONE NO : 510 413 2681 301 E Evelyn Ave SE DECISION MADE: 17-JAN-14 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVIS DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. 510(k) NO: K133833(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763 682 4139 1394 25TH STREET NW SE DECISION MADE: 17-JAN-14 BUFFALO MN 55313 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133424(SPECIAL) ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PKWY. SE DECISION MADE: 17-JAN-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOTION WATCH AND PRO-DIARY CAMNTECH, LTD 510(k) NO: K132764(TRADITIONAL) ATTN: HOWARD SMITH PHONE NO : 011 44 1480831223 UPPER PENDRILL COURT SE DECISION MADE: 21-JAN-14 PAPWORTH EVERARD, CAMBRIDGESHIRE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICRCO CLARITY VIEWER ICRCO INC. 510(k) NO: K132499(TRADITIONAL) ATTN: GREG WACHTLER PHONE NO : 310 921 9559 2580 WEST 237TH STREET SE DECISION MADE: 21-JAN-14 TORRANCE CA 90505 510(k) STATEMENT

DEVICE: A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM A.B. DENTAL DEVICES, LTD. 510(k) NO: K132125(TRADITIONAL) ATTN: DANIELA LEVY PHONE NO : 213 787 3026 22817 VENTURA BLVD #161 SE DECISION MADE: 21-JAN-14 WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM LAURA CATTABRIGA 510(k) NO: K130613(TRADITIONAL) ATTN: LAURA CATTABRIGA PHONE NO : 561 251 0876 7430 CENTER BAY DRIVE SE DECISION MADE: 22-JAN-14 N. BAY VILLAGE FL 33141 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANKYLOS SYNCONE ABUTMENT 5(DEGREE) DENTSPLY INTERNATIONAL, INC. 510(k) NO: K131644(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 487 1332 221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 22-JAN-14 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDS ULTRASONIC TIPS ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K132609(TRADITIONAL) ATTN: JEFFREY WAN PHONE NO : 201 487 9090 89 LEUNING STREET SUITE 8 SE DECISION MADE: 22-JAN-14 SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KESTREL POSTERIOR CERVICAL SPINE SYSTEM OMNI SURGICAL LLC DBA SPINE360 510(k) NO: K132122(TRADITIONAL) ATTN: DAVE LAMB PHONE NO : 512 327 6400 5000 PLAZA ON THE LAKE SUITE 305 SE DECISION MADE: 22-JAN-14 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT STANMORE IMPLANTS WORLDWIDE LTD. 510(k) NO: K133152(SPECIAL) ATTN: GERARD J PRUD’HOMME PHONE NO : 202 637 5735 555 THIRTEENTH ST, NW SE DECISION MADE: 22-JAN-14 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CO2 FRACTIONAL LASER BEIJING HONKON TECHNOLOGIES CO., L510(k) NO: K131837(TRADITIONAL) ATTN: MIKE GU PHONE NO : 86 20 62321333 7TH FL. JINGGUI BUSINESS BLDG NO. SE DECISION MADE: 22-JAN-14 GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, 510(k) NO: K133301(SPECIAL) ATTN: MARC O’GRIOFA PHONE NO : 702 614 3360 6412 S. ARVILLE ST. SE DECISION MADE: 22-JAN-14 LAS VEGAS NV 89118 89118 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP PEEK XP SPINAL IMPLANT SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K132421(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 22-JAN-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYPERION LONG PULSED ND: YAG LASER SCARLET RF, INC 510(k) NO: K132286(TRADITIONAL) ATTN: KEVIN J CHOI PHONE NO : 310 634 4480 28 STAFFORD DRIVE SE DECISION MADE: 22-JAN-14 WEST WINDSOR NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) INSTRUMENTATION LABORATORY CO. 510(k) NO: K132722(SPECIAL) ATTN: JACQUELINE EMERY PHONE NO : 781 861 4350 180 HARTWELL ROAD SE DECISION MADE: 22-JAN-14 BEDFORD MA 01730 510(k) STATEMENT

DEVICE: DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) INVIVO CORPORATION 510(k) NO: K133030(TRADITIONAL) ATTN: LISA SIMPSON PHONE NO : 352 336 0010 3545 SW 47TH AVE. SE DECISION MADE: 22-JAN-14 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VSP SYSTEMMEDICAL MODELING INC. 510(k) NO: K133907(SPECIAL)ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW SE DECISION MADE: 22-JAN-14WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES 510(k) NO: K133960(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 22-JAN-14 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS BIOMET MANUFACTURING CORP. 510(k) NO: K131135(TRADITIONAL) ATTN: CARMEN ALBANY PHONE NO : 574 371 3024 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 22-JAN-14 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) BIORETEC LTD. 510(k) NO: K133950(SPECIAL) ATTN: MINNA RASANEN PHONE NO : 358 20778 9500 HERMIANKATU 22, MODULIGTH BUILDINGSE DECISION MADE: 22-JAN-14 TAMPERE FI FI-33720 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN 510(k) NO: K133938(SPECIAL) ATTN: JOSE MARQUEZ PHONE NO : 508 452 4160 15 HAMPSHIRE STREET SE DECISION MADE: 22-JAN-14 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED CLOSURE SYSTEM STERILMED, INC. 510(k) NO: K133414(TRADITIONAL) ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483 11400 73RD AVENUE NORTH SE DECISION MADE: 22-JAN-14 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MPACT EXTENSION MEDACTA INTERNATIONAL 510(k) NO: K132879(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 322 3289 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 22-JAN-14 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE MEDRAD, INC. / BAYER MEDICAL CARE,510(k) NO: K132928(SPECIAL) ATTN: LISA A EWING PHONE NO : 412 767 2400 ONE MEDRAD DR. SE DECISION MADE: 23-JAN-14 INDIANOLA PA 15051 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KHAN KINETIC TREATMENT (KKT-M2) OPTIMA HEALTH SOLUTIONS INTERNATIO510(k) NO: K130666(TRADITIONAL) ATTN: FARHAD GHANI PHONE NO : 604 266 5338 303 – 828 W 8th Avenue SE DECISION MADE: 23-JAN-14 Vancouver CA V5Z 1E2 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEED 808 DIODE LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K132989(TRADITIONAL) ATTN: ZHANG XIAOSONG PHONE NO : 86 10 64354759 EAST 3RD FL, BLDG M7 # 1 JIUXIANQISE DECISION MADE: 23-JAN-14 CHAOYANG DISTRICT, BEIJING CH 1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 TOSOH BIOSCIENCE, INC. 510(k) NO: K131580(TRADITIONAL) ATTN: ROBERT L WICK PHONE NO : 650 636 8117 6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 23-JAN-14 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZYNO MEDICAL ADMINISTRATION SET ZYNO MEDICAL LLC 510(k) NO: K132841(SPECIAL) ATTN: MEI ZHANG, PHD PHONE NO : 508 650 2008 177 PINE ST SE DECISION MADE: 23-JAN-14 NATICK MA 01760 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRINDGUARD GRIND GUARD TECHNOLOGIES, LLC 510(k) NO: K133037(TRADITIONAL) ATTN: WILLIAM G MCLAIN PHONE NO : 717 656 9656 342 E. MAIN STREET SUITE 207 SE DECISION MADE: 23-JAN-14 LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K131490(TRADITIONAL) ATTN: JOHN MCINTYRE PHONE NO : 949 837 3600 13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 23-JAN-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JUVORA DENTQAL DISC JUVORA 510(k) NO: K132725(TRADITIONAL) ATTN: SELINA SHAW PHONE NO : 440 12 53898000 TECHNOLOGY CENTRE HILLHOUSE INTERNSE DECISION MADE: 23-JAN-14 THORNTON-CLEVELEYS, LANCASHIRE 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAREFINE PEN NEEDLE FACET TECHNOLOGIES 510(k) NO: K133100(TRADITIONAL) ATTN: MARY ANN KINARD PHONE NO : 770 590 6462 112 TOWN PARK DR. SUITE 300 SE DECISION MADE: 23-JAN-14 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 AAP IMPLANTATE AG 510(k) NO: K133675(TRADITIONAL) ATTN: CHRISTIAN ZIETSCH PHONE NO : 49 307501 9193 LORENZWEG 5 SE DECISION MADE: 23-JAN-14 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAC 2000 ECG ANALYSIS SYSTEM WIPRO GE HEALTHCARE 510(k) NO: K133622(TRADITIONAL) ATTN: DOUGLAS KENTZ PHONE NO : 414 581 8987 8200 WEST TOWER AVE SE DECISION MADE: 23-JAN-14 MILWAUKI WI 53223 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PUREGRAFT 50 SYSTEM CYTORI THERAPEUTICS, INC. 510(k) NO: K132815(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858 458 0900 3020 CALLAN ROAD SE DECISION MADE: 24-JAN-14 SAN DIEGO CA 92121 1109 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIVA VCF TREATMENT SYSTEM BENVENUE MEDICAL, INC. 510(k) NO: K132817(TRADITIONAL) ATTN: CINDY DOMECUS, R.A.C. (US &PHONE NO : 650 343 4813 1171 BARROILHET DR. SE DECISION MADE: 24-JAN-14 HILLSBOROUGH CA 94010 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARO 3 EP NAVIGATION SYSTEM, VERSION 3.2 BIOSENSE WEBSTER, INC. 510(k) NO: K132782(TRADITIONAL) ATTN: WAYNE R HOHMAN PHONE NO : 909 839 8597 3333 DIAMOND CANYON RD SE DECISION MADE: 24-JAN-14 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MPP MARC PRO 510(k) NO: K131910(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 24-JAN-14 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETAL ULTRASONIC MONITOR AND ACCESSORIESSHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K131457(TRADITIONAL)ATTN: FIELD FU PHONE NO : 86 755860 691974TH FLOOR, JINHUI BUILDING, NANHAISE DECISION MADE: 24-JAN-14SHENZHEN, GUANGDONG CH 518052 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE INVENTIS SRL 510(k) NO: K133013(TRADITIONAL) ATTN: MASSIMO MARTINELLI PHONE NO : 39 049896 2844 CORSO STATI UNITI 1/3 SE DECISION MADE: 24-JAN-14 PADOVA IT 35127 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YSIO MAX SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133259(SPECIAL) ATTN: DARREN DORMAN PHONE NO : 610 219 9066 51 VALLEY STREAM PKWY. SE DECISION MADE: 24-JAN-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K132300(TRADITIONAL) ATTN: JESSICA CHO PHONE NO : 949 713 8470 22872 AVENIDA EMPRESA SE DECISION MADE: 24-JAN-14 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNATRON PELTIER THERMOSTIM PROBE DYNATRONICS CORP. 510(k) NO: K132057(TRADITIONAL) ATTN: DOUGLAS SAMPSON PHONE NO : 801 568 7000 7030 PARK CENTRE DR. SE DECISION MADE: 24-JAN-14 Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS AESCULAP, INC. 510(k) NO: K131500(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 24-JAN-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPAD SAFEOP SURGICAL, INC. 510(k) NO: K132616(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 413 330 8578 125 CHERRY LN. SE DECISION MADE: 24-JAN-14 AMHERST MA 01002 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADD-VANTAGE ADDAPTOR HOSPIRA, INC. 510(k) NO: K133602(TRADITIONAL) ATTN: KAREN KEENER PHONE NO : 224 212 5316 375 N FIELD DRIVE SE DECISION MADE: 24-JAN-14 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133728(TRADITIONAL) ATTN: LAURA J DUGGAN, PH.D. PHONE NO : 302 631 7654 500 GBC DRIVEM/S 514 P.O. BOX 6101SE DECISION MADE: 24-JAN-14 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICURE CRYO MODULE SYSTEM ATRICURE, INC. 510(k) NO: K140058(SPECIAL) ATTN: KARL DAHLQUIST PHONE NO : 513 755 4100 6217 CENTRE PARK DRIVE SE DECISION MADE: 24-JAN-14 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K133726(SPECIAL) ATTN: RONDA MAGNESON PHONE NO : 801 576 9669 11506 SOUTH STATE ST. SE DECISION MADE: 24-JAN-14 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133987(SPECIAL) ATTN: JANIS F TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 24-JAN-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACY CATHETER HOSPI CORPORATION 510(k) NO: K133881(TRADITIONAL) ATTN: IGAL LADABAUM PHONE NO : 650 483 1035 2384 GEHRINGER DRIVE SE DECISION MADE: 24-JAN-14 CONCORD CA 95420 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW

DEVICE: SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ IBRAMED EQUIPAMENTOS MEDICOS 510(k) NO: K131309(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 377 0077 18851 NE 29TH AVE 720 SE DECISION MADE: 27-JAN-14 AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRITIUM STERNAL CABLE PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K133785(TRADITIONAL) ATTN: EMILY DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 27-JAN-14 Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET ROCHE DIAGNOSTICS 510(k) NO: K131244(TRADITIONAL) ATTN: EDIE EADS PHONE NO : 317 521 4668 9115 HAGUE ROAD SE DECISION MADE: 27-JAN-14 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K132638(TRADITIONAL) ATTN: LAURA J DUGGAN, PH.D. PHONE NO : 302 631 7654 500 GBC DRIVE M/S 514 P.O. BOX 610SE DECISION MADE: 27-JAN-14 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAMA SYSTEM MONTERIS MEDICAL 510(k) NO: K132444(TRADITIONAL) ATTN: BRIAN J EDWARDS PHONE NO : 763 253 4710 1193 SHERMAN STREET SE DECISION MADE: 27-JAN-14 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K133331(TRADITIONAL) ATTN: PETER J CORONADO PHONE NO : 650 424 6320 3100 HANSEN WAY SE DECISION MADE: 27-JAN-14 PALO ALTO CA 94304 94304 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVERSION PEDICLE SCREW SYSTEM K7 LLC 510(k) NO: K133103(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 27-JAN-14 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY RESONANCE INNOVATIONS LLC 510(k) NO: K133986(TRADITIONAL) ATTN: RANDALL JONES PHONE NO : 402 934 2650 9840 S 140th St Ste 8 SE DECISION MADE: 27-JAN-14 OMAHA NE 68138 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERI-PROSTHETIC CABLE SYSTEM BIOMET, INC. 510(k) NO: K133354(TRADITIONAL) ATTN: JULIE LARGENT PHONE NO : 305 269 6391 56 EAST BELL DR. SE DECISION MADE: 27-JAN-14 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRAFIX SMALL EXTERNAL FIXATION SYSTEM ZIMMER, INC. 510(k) NO: K131413(TRADITIONAL) ATTN: PHONE NO : P.O. BOX 708 SE DECISION MADE: 28-JAN-14 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEMEMERGE MEDICAL 510(k) NO: K133541(TRADITIONAL)ATTN: MICHELLE POTVIN PHONE NO : 720 459 6392 720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 28-JAN-14DENVER CO 80246 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTC PATCH WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K133723(ABBREVIATED) ATTN: CHIN-CHIN HSIEH PHONE NO : 886 229282 112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 28-JAN-14 YUNGHE CITY, TAIPEI COUNTY TW 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANCE CS CORONARY SINUS INFUSION CATHETER COOK, INC. 510(k) NO: K131204(TRADITIONAL) ATTN: JENNIFER RICHARDSON PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 29-JAN-14 Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOORLDLS-BI LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. 510(k) NO: K132163(TRADITIONAL) ATTN: XIABING HUANG PHONE NO : 44 129735 715 MILLWEY SE DECISION MADE: 29-JAN-14 AXMINSTER, DEVON UK EX135HU 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIWAY ENDONASAL ACCESS GUIDE SPIWAY LLC 510(k) NO: K132721(TRADITIONAL) ATTN: MARY LOU MOONEY PHONE NO : 949 922 2741 1046 LA MIRADA ST. SE DECISION MADE: 29-JAN-14 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UA-CELLULAR COMPLETE STRECK 510(k) NO: K131444(TRADITIONAL) ATTN: DEBORAH KIPP PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 29-JAN-14 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TANDEMHEART FEMORAL VENOUS CANNULA SET CARDIAC ASSIST, INC. 510(k) NO: K133236(TRADITIONAL) ATTN: GREG JOHNSON PHONE NO : 412 963 7770 240 ALPHA DR. SE DECISION MADE: 29-JAN-14 Pgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL CIBA VISION CORPORATION 510(k) NO: K133176(TRADITIONAL) ATTN: MARTINA HEIM, PH.D., RAC PHONE NO : 678 415 3565 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 29-JAN-14 DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADWELL FLEX EEG/PSG CADWELL INDUSTRIES, INC. 510(k) NO: K133355(TRADITIONAL) ATTN: JOHN CADWELL JR. PHONE NO : 509 735 6481 909 N Kellogg St SE DECISION MADE: 29-JAN-14 KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTURION POCT SYSTEM ORTHOFIX, INC. 510(k) NO: K131833(TRADITIONAL) ATTN: JACKI GEREN PHONE NO : 214 937 2100 3451 PLANO PARKWAY SE DECISION MADE: 30-JAN-14 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITANIUM SUTURE ANCHOR MTP SOLUTIONS LLC 510(k) NO: K133229(TRADITIONAL) ATTN: ROBERT HOY PHONE NO : 614 448 6358 124 SOUTH 600 WEST, SUITE 100 SE DECISION MADE: 30-JAN-14 LOGAN UT 84321 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MECTALIF TIPEEK MEDACTA INTERNATIONAL 510(k) NO: K133192(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 322 3289 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 30-JAN-14 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ELECTROCARDIOGRAPH SHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K132758(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 30-JAN-14 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UV PHOTOTHERAPY XUZHOU KERNEL MEDICAL EQUIPMENT CO510(k) NO: K132643(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 30-JAN-14 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DOME S10 NDS SURGICAL IMAGING 510(k) NO: K132770(TRADITIONAL) ATTN: JIM LENG PHONE NO : 408 776 0085 5750 HELLYER AVENUE SE DECISION MADE: 30-JAN-14 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER ACIST MEDICAL SYSTEMS 510(k) NO: K132474(TRADITIONAL) ATTN: MATTHEW STEPANEK PHONE NO : 952 995 9300 7905 FULLER ROAD SE DECISION MADE: 30-JAN-14 EDEN PRAIRIE MN 55344 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARDIS INTERBODY SYSTEM ZIMMER SPINE, INC 510(k) NO: K133184(TRADITIONAL) ATTN: MICHELLE LENZ PHONE NO : 952 830 6243 7375 BUSH LAKE RD. SE DECISION MADE: 30-JAN-14 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX BIOSUTURE ARTHREX, INC. 510(k) NO: K140019(SPECIAL) ATTN: COURTNEY SMITH PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 30-JAN-14 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XIRALITE FLOURESCENCE IMAGING SYSTEM X4 MIVENION GMBH 510(k) NO: K130003(TRADITIONAL) ATTN: MALTE BAHNER PHONE NO : 49 30 688379211 ROBERT-KOCH-PLATZ 4 SE DECISION MADE: 31-JAN-14 BERLIN GM 10115 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CASCADE HEMODIALYSIS/APHERESIS CATHETER HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K130851(TRADITIONAL) ATTN: NOLA BENSTOG PHONE NO : 801 773 7798 803 N. 1250 W. SUITE 1 SE DECISION MADE: 09-JAN-14 CENTERVILLE UT 84014 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), MARVAO MEDICAL DEVICES, LTD. 510(k) NO: K133796(SPECIAL) ATTN: CHRISTINE NICHOLS, RAC PHONE NO : 508 351 8632 368 WEST MAIN STREET SUITE 7 SE DECISION MADE: 31-JAN-14 NORTHBOROUGH MA 01532 510(k) SUMMARY AVAILABLE FROM FDA

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance