Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Medical Devices

June 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2013


DEVICE: HUMAN CAERULOPLASMIN KIT
THE BINDING SITE GROUP, LTD.      510(k) NO: K122965(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 0 1214569500
8 CALTHORPE ROAD WEST MIDLANDS    SE DECISION MADE: 03-JUN-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: VIDAS LYME IGM
BIOMERIEUX SA                     510(k) NO: K122979(TRADITIONAL)
ATTN: CATHERINE  FRITSCH          PHONE NO : 33 47 8872398
CHEMIN DE L ORME                  SE DECISION MADE: 04-JUN-13
MARCY L ETOILE    FR 69280        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K123423(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700   
3471 RIVER HILLS DRIVE            SE DECISION MADE: 05-JUN-13
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT CARBAMAZEPINE ASSAY
MICROGENICS CORPORATION           510(k) NO: K123518(TRADITIONAL)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD.               SE DECISION MADE: 05-JUN-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K120945(TRADITIONAL)
ATTN: ERIKA B AMMIRATI, RAC, MT(ASPHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K131051(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K131217(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 07-JUN-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K123785(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 07-JUN-13
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
EUROIMMUN US                      510(k) NO: K123261(TRADITIONAL)
ATTN: KATHRYN  KOHL               PHONE NO : 973 656 1000   
1100 THE AMERICAN ROAD            SE DECISION MADE: 12-JUN-13
MORRIS PLAINS NJ 07950            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP
ADVIN BIOTECH                     510(k) NO: K122809(TRADITIONAL)
ATTN: EDWARD  TUNG                PHONE NO : 858 668 8305   
6861 NANCY RIDGE DR.              SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFIA STREP A FIA
QUIDEL CORPORATION                510(k) NO: K123793(TRADITIONAL)
ATTN: JOHN D TAMERIUS, PH.D.      PHONE NO : 858 552 7908   
10165 MCKELLAR COURT              SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
MICOBIOMED CO, LTD                510(k) NO: K123016(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
55-13, SINGEONJI-DONG             SE DECISION MADE: 18-JUN-13
ANSEONG    KS 456-781             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
IMMUNODIAGNOSTIC SYSTEMS LTD.     510(k) NO: K123253(TRADITIONAL)
ATTN: MICK  FENTON                PHONE NO : 44 191 5190660
10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 18-JUN-13
BOLDON, TYNE & WEAR    UK NE35 9PD510(k) STATEMENT

DEVICE: VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
MICOBIOMED CO, LTD                510(k) NO: K123007(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
55-13, SINGEONJI-DONG             SE DECISION MADE: 19-JUN-13
ANSEONG    KS 456-781             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMAN ALBUMIN CSF KIT
THE BINDING SITE GROUP, LTD.      510(k) NO: K121045(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121456 9500
8 CALTHORPE ROAD                  SE DECISION MADE: 19-JUN-13
EDGBASTON    UK B15 1QT           510(k) STATEMENT

DEVICE: XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
CEPHEID                           510(k) NO: K130894(TRADITIONAL)
ATTN: RAINER  ZIERMANN PH.D.      PHONE NO : 408 400 4425   
904 CARIBBEAN DRIVE               SE DECISION MADE: 20-JUN-13
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT - 60 PLATE, AND SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE
ASTORIA-PACIFIC,INC.              510(k) NO: K121101(TRADITIONAL)
ATTN: CHARLES A PETERSON          PHONE NO : 503 657 3010   
15130 S.E. 82ND DR.               SE DECISION MADE: 20-JUN-13
CLACKAMAS OR 97015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K130914(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 21-JUN-13
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
LK CONSULTING GROUP               510(k) NO: K130295(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 844 2612   
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 21-JUN-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY  PHENCYCLIDINE
OMEGA LABORATORIES, INC.          510(k) NO: K131181(TRADITIONAL)
ATTN: ROBERT J BARD, JD, RAC, CQE PHONE NO : 248 563 5040   
400 NORTH CLEVELAND               SE DECISION MADE: 25-JUN-13
MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
BECTON, DICKINSON AND COMPANY     510(k) NO: K123266(TRADITIONAL)
ATTN: MONICA E GIGUERE            PHONE NO : 410 316 4287   
7 LOVETON CIRCLE, MC 614          SE DECISION MADE: 26-JUN-13
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
ABBOTT DIABETES CARE              510(k) NO: K130094(TRADITIONAL)
ATTN: DAVID G LAMBERT             PHONE NO : 510 749 5105   
1360 SOUTH LOOP RD                SE DECISION MADE: 27-JUN-13
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
BECTON, DICKINSON & CO.           510(k) NO: K123404(TRADITIONAL)
ATTN: MONICA E GIGURERE           PHONE NO : 410 316 4287   
7 LOVETON CIR.                    SE DECISION MADE: 27-JUN-13
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCAP ALLERGEN I3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN 14, PAPER WASP VENOM
PHADIA AB                         510(k) NO: K123275(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVENUE            SE DECISION MADE: 28-JUN-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
HILL-ROM                          510(k) NO: K122473(TRADITIONAL)
ATTN: ANN  WATERHOUSE             PHONE NO : 812 931 2634   
1069 STATE ROUTE 46 EAST          SE DECISION MADE: 03-JUN-13
BATESVILLE IN 47006               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
FOOTPRINT MEDICAL INC.            510(k) NO: K130507(SPECIAL)
ATTN: CLYDE N BAKER               PHONE NO : 210 226 2600   
12727 CIMARRON PATH               SE DECISION MADE: 03-JUN-13
SAN ANTONIO TX 78249              510(k) STATEMENT

DEVICE: VALVED TEARAWAY INTRODUCER GENERATION II
MEDICAL COMPONENTS INC            510(k) NO: K124046(TRADITIONAL)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 03-JUN-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
BISCO, INC.                       510(k) NO: K123653(TRADITIONAL)
ATTN: MICHELLE  SCHILTZ-TAING     PHONE NO : 847 534 6146   
1100 WEST IRVING PARK RD.         SE DECISION MADE: 03-JUN-13
Schaumburg IL 60193               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
OSTEOMED LP                       510(k) NO: K123885(TRADITIONAL)
ATTN: PIEDAD  PENA                PHONE NO : 972 677 4784   
3885 Arapaho Rd                   SE DECISION MADE: 03-JUN-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACHECK CURVE BLOOD PRESSURE CUFFS
STATCORP MEDICAL                  510(k) NO: K122365(TRADITIONAL)
ATTN: WAYNE  EMMERT               PHONE NO : 904 786 5113   
14476 Duval Pl W Ste 303          SE DECISION MADE: 04-JUN-13
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYOPLANT ONLAY
AESCULAP, INC.                    510(k) NO: K122791(TRADITIONAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076   
3773 CORPORATE PARKWAY            SE DECISION MADE: 04-JUN-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130640(TRADITIONAL)
ATTN: KRISTI  FRISCH              PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 04-JUN-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL OBLIQUE TLIF DEVICE
PINNACLE SPINE GROUP, LLC         510(k) NO: K124012(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 ELM ST STE 1930              SE DECISION MADE: 04-JUN-13
Dallas TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
INTEL-GE CARE INNOVATIONS LLC     510(k) NO: K130290(TRADITIONAL)
ATTN: MAUREEN  GLYNN              PHONE NO : 916 847 7794   
3721 DOUGLAS BOULEVARD SUITE 100  SE DECISION MADE: 04-JUN-13
ROSEVILLE CA 95661                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPUS PRO PATIENT MONITOR
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K130773(TRADITIONAL)
ATTN: CHRIS  HANNAN               PHONE NO : 44 1256 362400
THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 05-JUN-13
HAMPSHIRE    UK RG25 2HT          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRC-50DX RETINAL CAMERA
TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K123101(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 05-JUN-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROEPG SYSTEM
STROHL MEDICAL TECHNOLOGIES       510(k) NO: K123843(TRADITIONAL)
ATTN: JIM  GRECO                  PHONE NO : 603 401 0072   
8 GRAY LODGE RD                   SE DECISION MADE: 05-JUN-13
KITTERY ME 03904                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NOBELPROCERA PEEK ABUTMENTS
NOBEL BIOCARE AB                  510(k) NO: K120954(TRADITIONAL)
ATTN: PHUONG NGUYEN  SON          PHONE NO : 714 282 4800   
22715 SAVI RANCH PKWY.            SE DECISION MADE: 05-JUN-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
INSPIRX, INC.                     510(k) NO: K130598(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 05-JUN-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTSTRING III PROXIMAL SEAL SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K130382(TRADITIONAL)
ATTN: MARK  DINGER                PHONE NO : 973 709 7691   
45 BARBOUR POND DRIVE             SE DECISION MADE: 05-JUN-13
Wayne NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K131321(SPECIAL)
ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 05-JUN-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHOTON PHOTON PLUS
ZOLAR TECHNOLOGY & MFG. CO. INC.  510(k) NO: K122020(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 05-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: F&P SIMPLUS FULL FACE MASK
FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K130328(TRADITIONAL)
ATTN: SUE  CHO                    PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 05-JUN-13
AUCKLAND    NZ 2013               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K130427(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 05-JUN-13
MARQUETTE MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WART FREEZE
KONINKLIJKE UTERMOHLEN NV         510(k) NO: K130599(SPECIAL)
ATTN: KENNETH R MICHAEL           PHONE NO : 858 382 1331   
11956 BERNARDO PLAZA DR. #417     SE DECISION MADE: 05-JUN-13
SAN DIEGO CA 92128 1317           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRITICAL CARE VENTILATOR
ORICARE, INC.                     510(k) NO: K120931(TRADITIONAL)
ATTN: DAVID  JAMISON              PHONE NO : 215 538 2470   
1900 AM DRIVE                     SE DECISION MADE: 06-JUN-13
QUAKERTOWN PA 18951               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K131346(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 06-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130739(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694 5988   
685 East Middlefield Road         SE DECISION MADE: 06-JUN-13
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
SORIN GROUP ITALIA S.R.L.         510(k) NO: K131103(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 06-JUN-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K130149(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 06-JUN-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIZARD 230 NASAL PILOW MASK
APEX MEDICAL CORP.                510(k) NO: K121642(TRADITIONAL)
ATTN: FRANK  LIN                  PHONE NO : 886 222 685568
NO. 9, MINSHENG STREET            SE DECISION MADE: 06-JUN-13
TUCHENG CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUILION PRIME, V5.00
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K130645(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 06-JUN-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NATRATONE
ORELLE CORPORATION LTD            510(k) NO: K121902(TRADITIONAL)
ATTN: PATRICIA  COOMBES           PHONE NO : 206 420 4703   
4739 - 44TH AVE S.W., UNIT 403    SE DECISION MADE: 06-JUN-13
SEATTLE WA 98116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAS MEDICAL EQUIPMENT DRAPES
DAS MEDICAL, LLC                  510(k) NO: K121436(TRADITIONAL)
ATTN: ARMOND  GROVES              PHONE NO : 662 497 2866   
100 ROSECREST LANE                SE DECISION MADE: 06-JUN-13
COLUMBUS MS 39701                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
CORELEADER BIOTECH CO., LTD.      510(k) NO: K123394(TRADITIONAL)
ATTN: VINCENT  HUANG              PHONE NO : 886 2 26968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 06-JUN-13
NEW TAIPEI, TAIWAN    TW 22102    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTOR PTA BALLOON DILATATION CATHETER
R4 VASCULAR, INC.                 510(k) NO: K131329(SPECIAL)
ATTN: LAURIE  LEWANDOWSKI         PHONE NO : 612 771 4038   
738 SADDLE WOOD DR.               SE DECISION MADE: 06-JUN-13
EAGAN MN 55123                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
CONVATEC INC                      510(k) NO: K123481(TRADITIONAL)
ATTN: KATRINA  FIEDLER            PHONE NO : 908 904 2541   
200 HEADQUARTERS PARK DRIVE       SE DECISION MADE: 06-JUN-13
SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTBRACES CERAMIC BRACKETS
ORTHODONTIC DESIGN AND PRODUCTION,510(k) NO: K130446(TRADITIONAL)
ATTN: RICHARD  MERRELL            PHONE NO : 760 734 3995   
1370 DECISION STREET SUITE D      SE DECISION MADE: 07-JUN-13
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
CARESTREAM HEALTH,INC.            510(k) NO: K130464(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
150 VERONA STREET                 SE DECISION MADE: 07-JUN-13
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
ACCESS SCIENTIFIC, LLC            510(k) NO: K131300(SPECIAL)
ATTN: ALBERT  MISAJON             PHONE NO : 858 259 8333   
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 07-JUN-13
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISR'OBOT MONA LISA
BIOBOT SURGICAL PTE LTD           510(k) NO: K130944(SPECIAL)
ATTN: JOHN  BABY                  PHONE NO : 65 3150 7191
20 MAXWELL ROAD, #09-17, MAXWELL HSE DECISION MADE: 07-JUN-13
SINGAPORE    SN 069113            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
VIDAR SYSTEMS CORP.               510(k) NO: K130636(TRADITIONAL)
ATTN: CARRIE L BRANCART           PHONE NO : 703 471 7070   
365 Herndon Pkwy                  SE DECISION MADE: 07-JUN-13
HERNDON VA 20170                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4WEB OSTEOTOMY BONE WEDGE
4-WEB, INC.                       510(k) NO: K130185(TRADITIONAL)
ATTN: RICH  JANSEN, PHARM, D.     PHONE NO : 612 281 5505   
13540 GUILD AVE.                  SE DECISION MADE: 07-JUN-13
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEARING NSPVA EMBOLIZATION PARTICLES
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130259(TRADITIONAL)
ATTN: LINDA  VARROSO              PHONE NO : 781 681 7963   
1050 HINGHAM ST                   SE DECISION MADE: 07-JUN-13
ROCKLAND MA 02370                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIMACORPORATE SMR CTA HUMERAL HEADS
LIMACORPORATE S.P.A.              510(k) NO: K131112(SPECIAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 07-JUN-13
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMR SOFTWARE APPLICATION
PHILIPS HEALTHCARE (CLEVELAND)    510(k) NO: K123576(TRADITIONAL)
ATTN: CHRISTINE  ANDERSON         PHONE NO : 440 483 7732   
595 MINER RD.                     SE DECISION MADE: 07-JUN-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRELUDE SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130791(SPECIAL)
ATTN: MICHAELA  RIVKOWICH         PHONE NO : 801 208 4196   
1600 WEST MERIT PKWY.             SE DECISION MADE: 07-JUN-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XGEO GU60
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K123105(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 07-JUN-13
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
NDS SURGICAL IMAGING              510(k) NO: K131115(SPECIAL)
ATTN: JIM  LENG                   PHONE NO : 408 776 0085   
5750 HELLYER AVENUE               SE DECISION MADE: 07-JUN-13
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE 330PSI EXTENSION LINES
COEUR, INC.                       510(k) NO: K120892(TRADITIONAL)
ATTN: DEBRA F MANNING             PHONE NO : 615 547 7923   
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 10-JUN-13
LEBANON TN 37090                  510(k) STATEMENT

DEVICE: ACUMED TOTALW RIST FUSION PLATING SYSTEM
ACUMED LLC                        510(k) NO: K131380(SPECIAL)
ATTN: BRITTANY  CUNNINGHAM        PHONE NO : 503 207 1467   
5885 NW CORNELIUS PASS RD.        SE DECISION MADE: 10-JUN-13
HILLSBORO OR 97124 9432           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K130907(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 10-JUN-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARBAND
ORTHOMERICA PRODUCTS, INC.        510(k) NO: K124023(TRADITIONAL)
ATTN: DAVID L HOOPER              PHONE NO : 407 290 6592   
6333 N Orange Blossom Trl         SE DECISION MADE: 10-JUN-13
ORLANDO FL 32810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T3
MEDCOMP                           510(k) NO: K123292(TRADITIONAL)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256 4201   
1499 DELP DR.                     SE DECISION MADE: 11-JUN-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONENDO ENDOTHERAPY SYSTEM
SONENDO, INC.                     510(k) NO: K130025(TRADITIONAL)
ATTN: DAN W MILLER                PHONE NO : 949 766 3636   
26061 MERIT CIRCLE, SUITE 101     SE DECISION MADE: 11-JUN-13
LAGUNA HILLS CA 92653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENGLER 25K SERIES ULTRASONIC INSERTS
ENGLER ENGINEERING CORP.          510(k) NO: K122748(TRADITIONAL)
ATTN: JOEL  KATZ                  PHONE NO : 305 688 8581   
1099 EAST 47TH ST.                SE DECISION MADE: 11-JUN-13
HIALEAH FL 33013                  510(k) STATEMENT

DEVICE: DISPOSABLE CIRCULAR STAPLER
CHANGZHOU CITY ZHIYE MEDICAL DEVIC510(k) NO: K131303(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 931 625 4938   
12226 WASHINGTON LANE             SE DECISION MADE: 11-JUN-13
PARKER AZ 85344                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOMAT INSPIRATION PRIME
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123520(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 11-JUN-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHASSIST LED LIGHT FIBER
ENTELLUS MEDICAL, INC.            510(k) NO: K130503(TRADITIONAL)
ATTN: KAREN E PETERSON            PHONE NO : 763 463 7066   
3600 HOLLY LANE NORTH SUITE 40    SE DECISION MADE: 11-JUN-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENT SEAL
ITENA CLINICAL                    510(k) NO: K122521(TRADITIONAL)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 11-JUN-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR LONG LENGTH IMAGING SOFTWARE
CARESTREAM HEALTH, INC.           510(k) NO: K130567(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
150 VERONA STREET                 SE DECISION MADE: 11-JUN-13
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K131528(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
102 FIRST ST. SOUTH               SE DECISION MADE: 11-JUN-13
Kalona IA 52247                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Z-800 INFUSION SYSTEM
ZYNO MEDICAL LLC                  510(k) NO: K130690(SPECIAL)
ATTN: MEI  ZHANG PHD              PHONE NO : 508 650 2008   
177 PINE ST                       SE DECISION MADE: 12-JUN-13
NATICK MA 01760                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
MEDGYN PRODUCTS, INC.             510(k) NO: K122973(TRADITIONAL)
ATTN: STEPHANIE  BLAIR            PHONE NO : 408 286 8933   
12 SOUTH FIRST STREE 12TH FLOOR   SE DECISION MADE: 12-JUN-13
SAN JOSE CA 95113                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINT
HANSBIOMED CORPORATION            510(k) NO: K130191(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST UNIT B            SE DECISION MADE: 12-JUN-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VUSION CS PLUS
ORTHO DEVELOPMENT CORP.           510(k) NO: K122588(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 12-JUN-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMR 3-PEGS GLENOIDS
LIMACORPORATE S.P.A.              510(k) NO: K130642(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 12-JUN-13
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS TKO-6P LUER ACTIVATED DEVICE
NEXUS MEDICAL, LLC                510(k) NO: K130416(TRADITIONAL)
ATTN: HEATHER  TURNER             PHONE NO : 913 451 2234   
11315 STRANG LINE ROAD            SE DECISION MADE: 12-JUN-13
LENEXA KS 66215                   510(k) STATEMENT

DEVICE: SHASER V-MINI HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K130015(TRADITIONAL)
ATTN: SARAH  HACKETT              PHONE NO : 781 995 2251   
10 MAGUIRE RD STE 120 BUILDING ONESE DECISION MADE: 13-JUN-13
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIPELINE TOTAL HIP SYSTEM
PIPELINE ORTHOPEDICS              510(k) NO: K131237(SPECIAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET, SUITE 200        SE DECISION MADE: 13-JUN-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENTERAL NUTRITION WARMER
ACACIA, INC.                      510(k) NO: K122449(TRADITIONAL)
ATTN: FERGIE  FERGUSON            PHONE NO : 714 257 0470   
785 CHALLENGER ST.                SE DECISION MADE: 13-JUN-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDEWIRE, PURSUER SERIES
OSCOR INC.                        510(k) NO: K130104(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-JUN-13
PALM HARBOR FL 34683              510(k) STATEMENT

DEVICE: ORTHOSENSOR KNEE BALANCER
ORTHOSENSOR, INC.                 510(k) NO: K130380(SPECIAL)
ATTN: KIMBERLEE  WASHBURN         PHONE NO : 954 577 7770   
1560 SAWGRASS CORPORATE PKWY. 4TH SE DECISION MADE: 13-JUN-13
SUNRISE FL 33323                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATEAU SPACER SYSTEM TITANIUM
LIFE SPINE, INC                   510(k) NO: K130630(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 13-JUN-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE
WATCHDOG GROUP, LC                510(k) NO: K130753(TRADITIONAL)
ATTN: JOHN  O'HARA                PHONE NO : 314 721 5367   
7800 Forsyth Blvd. 8th Floor      SE DECISION MADE: 13-JUN-13
Clayton MO 63105                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTUM DENTAL IMPLANT SYSTEM
QUANTUM BIOENGINEERING, LTD.      510(k) NO: K130787(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
12264 EL CAMINO REAL, SUITE 400   SE DECISION MADE: 13-JUN-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIA AUTOMATED PD SYSTEM
DEKA RESEARCH & DEVELOPMENT CORP. 510(k) NO: K124018(TRADITIONAL)
ATTN: ROGER A LEROUX              PHONE NO : 603 669 5139   
340 COMMERCIAL ST.                SE DECISION MADE: 14-JUN-13
MANCHESTER NH 03101               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENFLOW IV FLUID WARMER INSULATED STRAP
VITAL SIGNS, INC., A GE HEALTHCARE510(k) NO: K130867(SPECIAL)
ATTN: STACIE  GEFFNER-ATIYA       PHONE NO : 973 956 5491   
20 CAMPUS RD                      SE DECISION MADE: 14-JUN-13
TOTOWA NJ 07512                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMORY CARDIAC TOOLBOX 3.2
SYNTERMED, INC.                   510(k) NO: K130902(TRADITIONAL)
ATTN: KENNETH  VAN TRAIN          PHONE NO : 888 263 4446   
245 SOUTH OWENS DRIVE             SE DECISION MADE: 14-JUN-13
ANAHEIM CA 92808                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K123810(TRADITIONAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 995115 11
11 HA'HOSHLIM STREET              SE DECISION MADE: 14-JUN-13
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHABNER XRT GARMENTS
BFFL CO. INC                      510(k) NO: K121284(TRADITIONAL)
ATTN: EVAN P PHELPS               PHONE NO : 202 789 1212   
600 NEW HAMPSHIRE AVENUE NW SUITE SE DECISION MADE: 14-JUN-13
WASHINGTON DC 20037               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNICUT RESECTION BLADE
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130912(TRADITIONAL)
ATTN: TATYANA  KORSUNSKY          PHONE NO : 508 828 3122   
325 PARAMOUNT DR.                 SE DECISION MADE: 14-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K130801(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755 26722890
4/F YIZHE BLDG, YUQUAN ROAD       SE DECISION MADE: 14-JUN-13
SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K130992(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
816 CONGRESS AVE, SUITE 1400      SE DECISION MADE: 14-JUN-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K130849(SPECIAL)
ATTN: MARKUS  STACHA              PHONE NO : 49 703146 32840
HEWLETT-PACKARD STR.2             SE DECISION MADE: 14-JUN-13
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEL-GEN COLD STORAGE SOLUTION
WATERS MEDICAL SYSTEMS, LLC       510(k) NO: K121618(TRADITIONAL)
ATTN: ROBERT  WARREN              PHONE NO : 800 426 9877   
2112 15TH ST. N.W.                SE DECISION MADE: 14-JUN-13
ROCHESTER MN 55901                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-MAX TOUCH 3D
OWANDY                            510(k) NO: K130443(ABBREVIATED)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 14-JUN-13
ORMOND BEACH FL 32176             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODULAP LOOP
ATC TECHNOLOGIES, INC.            510(k) NO: K121343(TRADITIONAL)
ATTN: JOHN  GILLESPIE             PHONE NO : 774 567 0277   
79 HAVEN STREET                   SE DECISION MADE: 14-JUN-13
DOVER MA 02030                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
MAINE STANDARDS CO.               510(k) NO: K123127(TRADITIONAL)
ATTN: JAMES W CHAMPLIN            PHONE NO : 800 377 9684   
765 ROOSEVELT TRAIL               SE DECISION MADE: 14-JUN-13
WINDHAM ME 04062 5365             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K121214(TRADITIONAL)
ATTN: KERRIE  OETTER              PHONE NO : 952 368 7858   
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 14-JUN-13
CHASKA MN 55318 1084              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K130542(TRADITIONAL)
ATTN: JYH-SHYAN  LIN              PHONE NO : 301 251 1092   
419 WEST AVE.                     SE DECISION MADE: 14-JUN-13
STAMFORD CT 06902 6300            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORC BODY
JOHARI DIGITAL HEALTHCARE, LTD.   510(k) NO: K131291(SPECIAL)
ATTN: POOJA  JOHARI               PHONE NO : 858 657 9226   
5703 OBERLIN DR. SUITE 306        SE DECISION MADE: 14-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASER HELMET
THERADOME INC.                    510(k) NO: K122950(TRADITIONAL)
ATTN: LARRY  PETERSEN             PHONE NO : 303 489 2500   
4900 HOPYARD ROAD SUITE 100       SE DECISION MADE: 14-JUN-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRAXEL DIAL 1550/1927 LASER SYSTEM
SOLTA MEDICAL, INC.               510(k) NO: K130193(TRADITIONAL)
ATTN: RAYMOND  LEE                PHONE NO : 510 259 7159   
25881 Industrial Blvd             SE DECISION MADE: 14-JUN-13
HAYWARD CA 94545                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PG-800A SERIES
SHENZHEN PANGO ELECTRONIC CO., LTD510(k) NO: K131569(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212281 5850
P.O. BOX 237-023                  SE DECISION MADE: 14-JUN-13
SHANGHAI    CH 200030             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
NUANCE MEDICAL, LLC               510(k) NO: K130995(TRADITIONAL)
ATTN: MARC S LIEBERMAN            PHONE NO : 760 525 4032   
300 CARLSBAD VILLAGE DRIVE, SUITE SE DECISION MADE: 14-JUN-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014" GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018"
TRIREME MEDICAL, INC.             510(k) NO: K130414(TRADITIONAL)
ATTN: SHIVA  ARDAKANI             PHONE NO : 925 931 1300   
7060 Koll Center Parkway Suite 300SE DECISION MADE: 15-JUN-13
Pleasanton CA 94566               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
DREAMCON CO., LTD                 510(k) NO: K123431(TRADITIONAL)
ATTN: ALBERT  REGO                PHONE NO : 949 770 8710   
27001 LA PAZ ROAD SUITE 312       SE DECISION MADE: 17-JUN-13
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
BIOMET MICROFIXATION              510(k) NO: K130309(TRADITIONAL)
ATTN: CHRISTINE  SCIFERT          PHONE NO : 901 831 8053   
3416 ROXEE RUN COVE               SE DECISION MADE: 17-JUN-13
BARTLETT TN 38133                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
WEILIN PLASTIC AND RUBBER PRODUCTS510(k) NO: K123590(TRADITIONAL)
ATTN: LING  ZHU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 17-JUN-13
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AZUR PUSHABLE 18 & 35 SYSTEM
MICROVENTION, INC.                510(k) NO: K130577(SPECIAL)
ATTN: CYNTHIA  VALENZUELA         PHONE NO : 714 247 8000   
1311 VALENCIA AVE                 SE DECISION MADE: 17-JUN-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STELLAR 150
RESMED GERMANY INC.               510(k) NO: K122715(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUMA CENTER BOULEVARD   SE DECISION MADE: 17-JUN-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC          510(k) NO: K130927(SPECIAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN ROAD                SE DECISION MADE: 18-JUN-13
WAUKEGAN IL 60085                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IU22 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K130499(TRADITIONAL)
ATTN: JESSICA  STENBERG           PHONE NO : 425 487 7371   
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 18-JUN-13
BOTHELL WA 98021 8431             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN REVERSE SHOULDER SYSTEM
ASCENSION ORTHOPEDIC              510(k) NO: K130050(TRADITIONAL)
ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 18-JUN-13
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
TACTILE SYSTEMS TECHNOLOGY INC    510(k) NO: K131193(TRADITIONAL)
ATTN: DAVE  HALVERSON             PHONE NO : 612 355 5100   
1331 Tyler St NE Ste 200          SE DECISION MADE: 18-JUN-13
MINNEAPOLIS MN 55413              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIKY UP
ENDOCONTROL                       510(k) NO: K122820(TRADITIONAL)
ATTN: HUGUEL  CARINE              PHONE NO : 334 766 37582
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 18-JUN-13
LA TRONCHE    FR 38700            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
EVENFLO FEEDING INCORPORATED      510(k) NO: K131153(TRADITIONAL)
ATTN: WADE  HALMA                 PHONE NO : 513 870 1629   
9277 Centre Pointe Dr Ste 160     SE DECISION MADE: 18-JUN-13
West Chester OH 45069             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VIVO 50
GE HEALTHCARE, BREAS MEDICAL AB   510(k) NO: K123144(TRADITIONAL)
ATTN: SHLOMI  DELER               PHONE NO : 972 989154 07
FORETAGSVAGEN 1                   SE DECISION MADE: 18-JUN-13
MOLNLYCKE    SW 435 33            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTI LEAD TRIAL CABLE
ST. JUDE MEDICAL                  510(k) NO: K130545(TRADITIONAL)
ATTN: LAKSHMI  PADMANABHAN        PHONE NO : 972 526 8262   
6901 PRESTON ROAD                 SE DECISION MADE: 18-JUN-13
PLANO TX 75024                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K130563(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 28227 1300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 18-JUN-13
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
BIOPRO, INC.                      510(k) NO: K130298(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH ST                  SE DECISION MADE: 18-JUN-13
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
OSTEOMED LP                       510(k) NO: K131445(SPECIAL)
ATTN: BLESSON  ABRAHAM            PHONE NO : 972 677 4795   
3885 Arapaho Rd                   SE DECISION MADE: 18-JUN-13
ADDISON TX 75001                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
TYSON BIORESEARCH, INC.           510(k) NO: K123087(SPECIAL)
ATTN: WEN-HAI  TSAI               PHONE NO : 886 375859 88
5 F., # 22, KE E. ROAD III SCIENCESE DECISION MADE: 18-JUN-13
CHUN-NAN, MIAO-LI COUNTY    TW 350510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIVERSAL DISTAL RADIUS SYSTEM
NEWCLIP TECHNICS                  510(k) NO: K130774(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD.                SE DECISION MADE: 19-JUN-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JOULE 810/940/980 MULTI-PLATFORM SYSTEM
SCITON, INC.                      510(k) NO: K122567(TRADITIONAL)
ATTN: JAY M PATEL                 PHONE NO : 650 493 9155   
925 COMMERCIAL STREET             SE DECISION MADE: 19-JUN-13
Palo Alto CA 94303                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
GE HEALTHCARE                     510(k) NO: K131267(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 W INNOVATION DRIVE           SE DECISION MADE: 19-JUN-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLL- V1 LIGHT SOURCE
OLYMPUS WINTER & IBE GMBH         510(k) NO: K130819(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PKWAY              SE DECISION MADE: 19-JUN-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z5 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K130695(TRADITIONAL)
ATTN: WU  ZICUI                   PHONE NO : 86 755 81885635
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 19-JUN-13
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
RANDOX LABORATORIES LIMITED       510(k) NO: K130337(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 28 94422413
55 DIAMOND ROAD                   SE DECISION MADE: 19-JUN-13
CRUMLIN, ANTRIM    UK BT29 4QY    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK BLOOD PRESSURE MONITOR
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K131395(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 19-JUN-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BASIXTOUCH
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K130566(SPECIAL)
ATTN: DAN W LINDSAY               PHONE NO : 801 208 4408   
1600 WEST MERIT PKWY.             SE DECISION MADE: 19-JUN-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
HEALTH & LIFE CO., LTD.           510(k) NO: K130564(TRADITIONAL)
ATTN: SARAH  SU                   PHONE NO : 886 28227 1300
9F, NO.186, JIAN YI ROAD          SE DECISION MADE: 19-JUN-13
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COALIGN INNOVATIONS ACCULIF XL IBF CAGE
COALIGN INNOVATIONS, INC.         510(k) NO: K131443(SPECIAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 19-JUN-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRCAST VENAFLOW ELITE SYSTEM
DJO, LLC                          510(k) NO: K130722(TRADITIONAL)
ATTN: LORRI  TROTTER              PHONE NO : 760 734 3049   
1430 DECISION STREET              SE DECISION MADE: 20-JUN-13
VISTA CA 92081 8553               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROW GPSCATH BALLOON DILATATION CATHETER
HOTSPUR TECHNOLOGIES              510(k) NO: K130397(TRADITIONAL)
ATTN: ERIC  ANKERUD, JD           PHONE NO : 978 302 9467   
880 MAUDE AVENUE SUITE A          SE DECISION MADE: 20-JUN-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFORM PEDICLE SCREW SYSTEM
SPINAL USA                        510(k) NO: K130279(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 264 9937   
4628 NORTHPARK DRIVE              SE DECISION MADE: 20-JUN-13
COLORADO SPRINGS MS 39208         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUTURABOND  UNIVERSAL
VOCO GMBH                         510(k) NO: K130486(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 49 4721 719200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 20-JUN-13
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: CELLTRACKS ANALYZER II SYSTEM
VERIDEX, LLC                      510(k) NO: K130794(TRADITIONAL)
ATTN: KIMBERLY  PRESCOTT          PHONE NO : 908 927 4947   
1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 20-JUN-13
RARITAN NJ 08869 0606             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPEDIUM SPINE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K130877(TRADITIONAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 20-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITAN
INTERACOUSTICS A/S                510(k) NO: K130795(TRADITIONAL)
ATTN: ERIK  NIELSEN               PHONE NO : 45 637 13555
DREJERVAENGET 8                   SE DECISION MADE: 20-JUN-13
ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K123106(TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 20-JUN-13
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K130217(TRADITIONAL)
ATTN: MARK  FOX                   PHONE NO : 574 268 6379   
2850 FRONTIER DRIVE               SE DECISION MADE: 20-JUN-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSIOLOGICAL DATA PROCESSOR
ZEPHYR TECHNOLOGY CORPORATION     510(k) NO: K122763(TRADITIONAL)
ATTN: RICHARD  KEEN               PHONE NO : 203 329 2700   
1151 HOPE STREET                  SE DECISION MADE: 20-JUN-13
STAMFORD CT 06907                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
AMERICAN SURGICAL COMPANY, LLC    510(k) NO: K112598(SPECIAL)
ATTN: MICHAEL  ALOUANE            PHONE NO : 781 592 7200   
82 SANDERSON AVENUE               SE DECISION MADE: 20-JUN-13
Lynn MA 01902                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
PROCTER & GAMBLE CO.              510(k) NO: K131543(SPECIAL)
ATTN: KATHLEEN  BLIESZNER         PHONE NO : 513 634 3168   
6110 CENTER HILL AVE.             SE DECISION MADE: 20-JUN-13
CINCINNATI OH 45224               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
BEDSIDE CLINICAL SYSTEMS INC      510(k) NO: K124038(TRADITIONAL)
ATTN: DIANE  SUDDUTH              PHONE NO : 512 327 9997   
611 WEST 5TH STREET, THIRD FLOOR  SE DECISION MADE: 21-JUN-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ION MAGNUM GENIUS
ION GENIUS INC                    510(k) NO: K123158(TRADITIONAL)
ATTN: XANYA  SOFRA-WEISS          PHONE NO : 808 395 0656   
7192 KALANIANAOLE HWY #D-204A     SE DECISION MADE: 21-JUN-13
HONOLULU HI 96821                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K131131(SPECIAL)
ATTN: STEVE  KWON                 PHONE NO : 408 747 9876   
3550 WILSHIRE BLVD #738           SE DECISION MADE: 21-JUN-13
LOS ANGELES CA 90010 2401         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MFM-CMS CENTRAL MONITORING SYSTEM
EDAN INSTRUMENTS INC              510(k) NO: K120727(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 867 552 6856469
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 21-JUN-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
NEURO RESOURCE GROUP, INC.        510(k) NO: K130816(TRADITIONAL)
ATTN: DAVID  TURNER               PHONE NO : 972 665 1810   
1100 JUPITER RD., STE. 190        SE DECISION MADE: 21-JUN-13
PLANO TX 75074                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K131213(TRADITIONAL)
ATTN: TOKI  WU                    PHONE NO : 86 755267 22890
YIZHE BLDG., YUQUAN RD            SE DECISION MADE: 21-JUN-13
SHENZHEN, GUANGDONG    CH 518051  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERRATA PRESSURE GUIDE WIRE
VOLCANO CORPORATION               510(k) NO: K131288(SPECIAL)
ATTN: JWALA  JAWHARKAR            PHONE NO : 916 281 2925   
2870 KILGORE RD.                  SE DECISION MADE: 21-JUN-13
RANCHO CORDOVA CA 95670           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OAK RIDGE PRODUCTS SHARP CONTAINER
OAK RIDGE PRODUCTS, LLC           510(k) NO: K130281(ABBREVIATED)
ATTN: TIBOR B KOVARI              PHONE NO : 815 363 4700   
4612 Century Ct                   SE DECISION MADE: 21-JUN-13
McHenry IL 60050                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TEZO TITANIUM CAGE FAMILY
ULRICH GMBH & CO. KG              510(k) NO: K122957(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268   
612 TRADE CENTER BLVD             SE DECISION MADE: 21-JUN-13
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYRDROMAX HMEF
A-M SYSTEMS                       510(k) NO: K130664(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 21-JUN-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
ENCORE MEDICAL, L.P.              510(k) NO: K130099(SPECIAL)
ATTN: WILLIAM  GARZON             PHONE NO : 512 834 6391   
9800 METRIC BLVD.                 SE DECISION MADE: 21-JUN-13
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K130833(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN           PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 21-JUN-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTAIN BELLATEK PROVISIONAL ABUTMENTS
BIOMET 3I                         510(k) NO: K130310(TRADITIONAL)
ATTN: JACQUELYN A HUGHES, RAC     PHONE NO : 561 776 6840   
4555 RIVERSIDE DR.                SE DECISION MADE: 21-JUN-13
Palm Bch Gdns FL 33410            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
PROTEUS DIGITAL HEALTH, INC.      510(k) NO: K131524(SPECIAL)
ATTN: ZAHEDEH  HATAMKHANY         PHONE NO : 650 637 6109   
2600 BRIDGE PARKWAY, SUITE 101    SE DECISION MADE: 23-JUN-13
REDWOOD CITY CA 94065             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSLEEVE
RIJUVEN CORP                      510(k) NO: K131287(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 24-JUN-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEALTH 360 ORBITAL PAD SYSTEM
CARDIO SYSTEMS, INC.              510(k) NO: K131092(SPECIAL)
ATTN: MAUREEN  MCDONNELL          PHONE NO : 651 259 1644   
651 CAMPUS DRIVE                  SE DECISION MADE: 24-JUN-13
SAINT PAUL MN 55112 3495          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAWMAX DILATOR
LIFETECH SCIENTIFIC (SHENZHEN) CO.510(k) NO: K123842(TRADITIONAL)
ATTN: LILY  SHI                   PHONE NO : 86 755860 26416
LANGSHAN 2ND STREET NANSHAN DISTRISE DECISION MADE: 24-JUN-13
SHENZHENG, GUANGDONG    CH 518057 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHANGRING
WUHU SNNDA MEDICAL TREATMENT APPLI510(k) NO: K131373(SPECIAL)
ATTN: BO  GONG                    PHONE NO : 86 21 64957283
503 ROOM, 8 BUILDING, 600 LIU ZHOUSE DECISION MADE: 25-JUN-13
SHANGHAI    CH 200233             510(k) STATEMENT

DEVICE: DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
I.T.S. GMBH                       510(k) NO: K130008(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 25-JUN-13
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM ("EPI MINI")
EPI MOBILE HEALTH SOLUTIONS (S) PT510(k) NO: K121628(TRADITIONAL)
ATTN: KARL M NOBERT               PHONE NO : 202 626 6630   
1200 19TH STREET, NW              SE DECISION MADE: 25-JUN-13
WASHINGTON DC 20032               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
PYNG MEDICAL CORP.                510(k) NO: K130487(TRADITIONAL)
ATTN: MICHELE  TYLER              PHONE NO : 604 303796 4
13480 CRESTWOOD PLACE UNIT 210    SE DECISION MADE: 25-JUN-13
RICHMOND, BC    CA V6V 2J9        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFINI RADIOFREQUENCY SYSTEM
LUTRONIC CORPORATION              510(k) NO: K121481(TRADITIONAL)
ATTN: JHUNG  WON VOJIR            PHONE NO : 215 205 2219   
6 NESHAMINY INTERPLEX, SUITE 207  SE DECISION MADE: 25-JUN-13
TREVOSE PA 19053                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
NEURO THERM, INC.                 510(k) NO: K122503(TRADITIONAL)
ATTN: F. DAVID  ROTHKOPF          PHONE NO : 508 231 8842   
200 HOMER AVE                     SE DECISION MADE: 25-JUN-13
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
SWISSRAY MEDICAL AG               510(k) NO: K131314(TRADITIONAL)
ATTN: TODD  SHOPP                 PHONE NO : 
TURBISTRASSE 25-27                SE DECISION MADE: 25-JUN-13
HOCHDORF, LU    SZ 6280           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EBA2 FEMORAL NAILING SYSTEM
CITIEFFE S.R.L.                   510(k) NO: K131005(SPECIAL)
ATTN: CLAUDE  BERTHION            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD SUITE 209     SE DECISION MADE: 25-JUN-13
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
TRACTUS CORPORATION               510(k) NO: K131489(TRADITIONAL)
ATTN: MARK  JOB                   PHONE NO : 763 682 4139   
1394 25TH ST. NW                  SE DECISION MADE: 25-JUN-13
BUFFALO MN 55313                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KSEA BIPOLAR ELECTRODE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K122983(TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 424 218 8379   
2151 E. GRAND AVE.                SE DECISION MADE: 26-JUN-13
EL SEGUNDO CA 90245               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEMOCONCENTRATOR
MAQUET CARDIOPULMONARY AG         510(k) NO: K123288(TRADITIONAL)
ATTN: INGRID  RICHTER             PHONE NO : 011 497222 9320
KEHLER STRASSE 31                 SE DECISION MADE: 26-JUN-13
RASTATT    GM 76437               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONITOR B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K130584(TRADITIONAL)
ATTN: CASARSA  ROBERT             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE               SE DECISION MADE: 26-JUN-13
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 23GA CURVED ILLUMINATING LASER PROBE
PEREGRINE SURGICAL LTD.           510(k) NO: K122997(SPECIAL)
ATTN: RYAN  O'LEARY               PHONE NO : 215 348 0456   
51 BRITAIN DR.                    SE DECISION MADE: 26-JUN-13
NEW BRITAIN PA 18901              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
CARL ZEISS MEDITEC INC            510(k) NO: K130549(TRADITIONAL)
ATTN: SARAH  HARRINGTON           PHONE NO : 925 560 5134   
5160 HACIENDA DR.                 SE DECISION MADE: 26-JUN-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K131556(SPECIAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 26-JUN-13
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASERBRUSH
SUNETICS INTERNATIONAL MARKETING G510(k) NO: K121920(TRADITIONAL)
ATTN: JOHN  CARULLO               PHONE NO : 214 683 0724   
892 STEGER TOWNE RD  #44          SE DECISION MADE: 27-JUN-13
ROCKWALL TX 75032                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE TL SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K131100(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 27-JUN-13
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXLE INTERSPINOUS FUSION SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K130438(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN, M.D.      PHONE NO : 937 847 8400   
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 27-JUN-13
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LYRIC2
PHONAK LLC                        510(k) NO: K130790(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 27-JUN-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EARPROBE
PATH MEDICAL GMBH                 510(k) NO: K131141(TRADITIONAL)
ATTN: JOHANN  OSWALD              PHONE NO : 004 989 80076502
LANDSBERGER STR 63                SE DECISION MADE: 27-JUN-13
GERMERING, BAVARIA    GM D-82110  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
SENORX, INC.                      510(k) NO: K131654(SPECIAL)
ATTN: SARAH  MCCARTNEY            PHONE NO : 480 638 2954   
1625 WEST 3RD STREET              SE DECISION MADE: 27-JUN-13
TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEELER SLIT LAMP H-SERIES
KEELER LTD.                       510(k) NO: K131589(ABBREVIATED)
ATTN: NICKIE  POWER               PHONE NO : 44 175382 7153
CLEWER HILL RD.                   SE DECISION MADE: 27-JUN-13
WINDSOR, BERKSHIRE    UK SL4 4AA  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K131683(SPECIAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DRIVE               SE DECISION MADE: 27-JUN-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURECALL LABOR MONITOR
REPRODUCTIVE RESEARCH TECHNOLOGIES510(k) NO: K130002(TRADITIONAL)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 832 675 9281   
1770 ST. JAMES, STE 600           SE DECISION MADE: 28-JUN-13
HOUSTON TX 77056 3433             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUDO PATH
LD TECHNOLOGY LLC                 510(k) NO: K131568(SPECIAL)
ATTN: ALBERT  MAAREK              PHONE NO : 305 379 9900   
100 N. BISCAYNE BLVD, STE 500     SE DECISION MADE: 28-JUN-13
MIAMI FL 33132                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIRVANA D PERSONAL LUBRICANT (TBD)
CHURCH & DWIGHT CO., INC.         510(k) NO: K123427(TRADITIONAL)
ATTN: EMILY  PEREZ                PHONE NO : 609 688 5347   
469 NORTH HARRISON STREET         SE DECISION MADE: 28-JUN-13
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ET SMARTFIT ABUTMENT
HIOSSEN INC.                      510(k) NO: K123627(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DRIVE             SE DECISION MADE: 28-JUN-13
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130638(TRADITIONAL)
ATTN: KLIEN  VAN DAM              PHONE NO : 310 402795 225
VEENPLUIS 4-6                     SE DECISION MADE: 28-JUN-13
BEST    NT 5694 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
BIOTEST MEDICAL CORP.             510(k) NO: K123559(TRADITIONAL)
ATTN: FRED  LEE                   PHONE NO : 886 425326 668
NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZSE DECISION MADE: 28-JUN-13
TAICHUNG    TW 42760              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVITIVE IX
ACTEGY LTD                        510(k) NO: K123354(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 13TH STREET, NW               SE DECISION MADE: 28-JUN-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
STRAUMANN USA                     510(k) NO: K130724(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 28-JUN-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
SMITH & NEPHEW, INC.              510(k) NO: K123598(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 339 6339   
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 28-JUN-13
CORDOVA TN 38016                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
STRAUMANN USA                     510(k) NO: K130808(SPECIAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 28-JUN-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CODA BALLOON CATHETER
COOK, INC.                        510(k) NO: K122917(SPECIAL)
ATTN: ELYSIA  EASTON              PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 28-JUN-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOE FLUID STATUS MONITOR
NONINVASIVE MEDICAL TECHNOLOGIES, 510(k) NO: K131509(SPECIAL)
ATTN: MARC  O'GRIOFA              PHONE NO : 702 614 3360   
6412 S. ARVILLE STREET            SE DECISION MADE: 28-JUN-13
LAS VEGAS NV 89118                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKVUE INFLUENZA A+B
QUIDEL CORP.                      510(k) NO: K131619(SPECIAL)
ATTN: JOHN D TAMERIUS             PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 28-JUN-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
KIMBERLY-CLARK CORPORATION        510(k) NO: K122653(TRADITIONAL)
ATTN: DAVID  LEE                  PHONE NO : 770 587 7167   
1400 HOLCOMB BRIDGE RD. BLDG 300/1SE DECISION MADE: 26-JUN-13
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
INTUITIVE SURGICAL, INC.          510(k) NO: K130726(SPECIAL)
ATTN: MELISSA S GONZALEZ          PHONE NO : 408 523 8684   
1266 KIFER ROAD BUILDING 101      SE DECISION MADE: 07-JUN-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   211                                     
                                                 TOTAL WITH SUMMARIES        200                                     
                                                 TOTAL WITH STATEMENTS        11
                                      

Page Last Updated: 01/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.