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Medical Devices

January 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2014


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: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS           510(k) NO: K133038(TRADITIONAL)
ATTN: CINDY  KNAPP                PHONE NO : 800 871 8909   
1 THERMO FISHER WAY               SE DECISION MADE: 31-JAN-14
OAKWOOD VILLAGE OH 44146          510(k) STATEMENT

DEVICE: WONDFO RAPID STREP A TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K133343(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 31-JAN-14
GAITHERSBURG MD 20878             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: CARDIOCEL
CELXCEL PTY LTD                   510(k) NO: K130872(TRADITIONAL)
ATTN: CHRISTOPHER  SLOAN          PHONE NO : 301 272 3114   
1801 ROCKVILLE PIKE, SUITE 300    SE DECISION MADE: 30-JAN-14
ROCKVILLE MD 20852                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG WALLY PLASTICS CO., L510(k) NO: K131344(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 108238 7441
RM.1606, BLD.1 JIANXIANG YUAN NO.2SE DECISION MADE: 30-JAN-14
BEIJING    CH 100083              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: BOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
NOBEL BIOCARE USA, LLC            510(k) NO: K132746(TRADITIONAL)
ATTN: PHUONG  NGUYEN              PHONE NO : 714 282 4800   
22715 SAVI RANCH PKWY.            SE DECISION MADE: 30-JAN-14
YORBA LINDA CA 92887              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: MINI TIGHTROPE
ARTHREX, INC.                     510(k) NO: K133275(TRADITIONAL)
ATTN: NANCY  HOFT                 PHONE NO : 239 598 5553   
1370 Creekside Blvd               SE DECISION MADE: 30-JAN-14
Naples FL 34108                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRUX SNARE FILTER RETRIEVAL SET
VOLCANO CORPORATION               510(k) NO: K133681(TRADITIONAL)
ATTN: ELISA  HEBB                 PHONE NO : 858 720 4184   
1 FORTUNE DR                      SE DECISION MADE: 30-JAN-14
BILLERICA MA 01821                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: AVD RIGHT RADIAL DRAPE
ADVANCED VASCULAR DYNAMICS        510(k) NO: K131571(TRADITIONAL)
ATTN: MATTHEW  SEMLER             PHONE NO : 503 525 6382   
4252 SE International Way Ste F   SE DECISION MADE: 31-JAN-14
Milwaukie OR 97222                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
DANIELS SHARPSMART, INC.          510(k) NO: K132792(TRADITIONAL)
ATTN: ALLISON  KOMIYAMA           PHONE NO : 858 792 1235   
12264 EL CAMINO REAL, STE #400    SE DECISION MADE: 31-JAN-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
SCICAN GMBH                       510(k) NO: K132356(TRADITIONAL)
ATTN: JOSEF  SILLET               PHONE NO : 49 7561 983430
WANGENER STR. 78                  SE DECISION MADE: 31-JAN-14
LEUTKIRCH    GM 88299             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RAYPEX 6
DENTSPLY INTERNATIONAL INC.       510(k) NO: K131907(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 487 1332   
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 31-JAN-14
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VESALIUS
TELEA ELECTRONIC ENGINEERING SRL  510(k) NO: K131696(TRADITIONAL)
ATTN: TESTA  MARISA               PHONE NO : 39 054264 3496
VIA SARAGAT 5                     SE DECISION MADE: 31-JAN-14
IMOLA, BO    IT 40026             510(k) STATEMENT

DEVICE: ENLIGHTN RENAL GUIDE CATHETER
ST. JUDE MEDICAL, INC.            510(k) NO: K131592(TRADITIONAL)
ATTN: BLAIR  SCHWARTZ             PHONE NO : 651 756 2706   
5050 NATHAN LANE NORTH            SE DECISION MADE: 31-JAN-14
PLYMOUTH MN 55442                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LINA GOLD LOOP HC
LINA MEDICAL APS                  510(k) NO: K132135(TRADITIONAL)
ATTN:                             PHONE NO : 
386 WEST MAIN ST. SUITE 7         SE DECISION MADE: 31-JAN-14
NORTHBOROUGH MA 01532             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ F SERIES
GE HEALTHCARE                     510(k) NO: K133034(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 31-JAN-14
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHANDONG HAOYU MEDICAL PRODUCTS CO510(k) NO: K132221(TRADITIONAL)
ATTN: RAY  ZHOU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 31-JAN-14
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIAN MULTILEAF COLLIMATOR
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K133240(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
3100 HANSEN WAY                   SE DECISION MADE: 31-JAN-14
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDSOURCE IV SAFETY CATHETER
MEDSOURCE INTERNATIONAL, LLC.     510(k) NO: K131555(TRADITIONAL)
ATTN: JENNIFER  NESS              PHONE NO : 952 472 0131   
5346 SHORELINE DR.                SE DECISION MADE: 31-JAN-14
MOUND MN 55364                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
WELCH ALLYN, INC.                 510(k) NO: K132807(SPECIAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 31-JAN-14
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITA SUPRINITY(R)
VITA ZAHNFABRIK H. RAUTER GMBH & C510(k) NO: K132070(ABBREVIATED)
ATTN: NEVINE  ERIAN               PHONE NO : 949 370 7155   
3150 EAST BIRCH STREET            SE DECISION MADE: 31-JAN-14
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIANCE V2
GMV SOLUCIONES GLOBALES INTERNET S510(k) NO: K133655(TRADITIONAL)
ATTN: ALBERT  KOSTER              PHONE NO : 316 22 694211
ASTERWEG 19                       SE DECISION MADE: 31-JAN-14
AMSTERDAM, NOORD HOLLAND    NT 103510(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: INTERBODY CAGE SYSTEM
AURORA SPINE                      510(k) NO: K133967(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 31-JAN-14
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREEZY ELEGANCE
SUNRISE MEDICAL (US) LLC          510(k) NO: K133855(TRADITIONAL)
ATTN: LAURIE H ROBERTS            PHONE NO : 559 292 2171   
2842 BUSINESS PARK AVE            SE DECISION MADE: 31-JAN-14
FRESNO CA 93727                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SORIN FLEXTHERM
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K140012(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W 65TH WAY                  SE DECISION MADE: 31-JAN-14
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CO PILOT/REGIUS UNITEA
KONICA MINOLTA INC.               510(k) NO: K133730(TRADITIONAL)
ATTN: RUSSELL  MUNVES             PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FL TWO GRASE DECISION MADE: 31-JAN-14
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 6MP COLOR LCD MONITOR, RADIFORCE RX650
EIZO CORPORATION                  510(k) NO: K134002(TRADITIONAL)
ATTN: TOSHIMINE  HIRAKI           PHONE NO : 817 62 742468
153 SHIMOKASHIWANO                SE DECISION MADE: 31-JAN-14
HAKUSAN, ISHIKAWA    JA 924-8566  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


                                                 TOTAL 510(k)s THIS PERIOD   255                                     
                                                 TOTAL WITH SUMMARIES        239                                     
                                                 TOTAL WITH STATEMENTS        16
                                      

 

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