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-LEVEL
ELITECH 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-14
BOTHELL 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 M15
SOURCE PRODUCTION & EQUIPMENT CO.,510(k) NO: K132969(TRADITIONAL)
ATTN: KELLEY RICHARDT PHONE NO : 504 464 9471
113 Teal St. SE DECISION MADE: 02-JAN-14
Saint 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 DEVICES
ORTHOHELIX 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-14
Medina 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 CUTTER
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K133736(TRADITIONAL)
ATTN: ERIC MAYNARD PHONE NO : 440 639 4494
5976 HEISELY RD. SE DECISION MADE: 07-JAN-14
MENTOR 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 2202
B-K MEDICAL APS 510(k) NO: K132346(TRADITIONAL)
ATTN: RANDI HAUERBERG PHONE NO : 45 445281 00
MILEPARKEN 34 SE DECISION MADE: 10-JAN-14
HERLEV 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 SYSTEM
CORELINK LLC 510(k) NO: K133369(SPECIAL)
ATTN: J D WEBB PHONE NO : 512 388 0199
1001 OAKWOOD BLVD SE DECISION MADE: 14-JAN-14
ROUND 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 SYSTEM
ICONACY 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-14
WARSAW 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 SYSTEM
MEDICAL 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-14
WASHINGTON 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 ACCESSORIES
SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K131457(TRADITIONAL)
ATTN: FIELD FU PHONE NO : 86 755860 69197
4TH FLOOR, JINHUI BUILDING, NANHAISE DECISION MADE: 24-JAN-14
SHENZHEN, 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 SYSTEM
EMERGE 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-14
DENVER 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
