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U.S. Department of Health and Human Services

Medical Devices

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Marchl 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2013
 
 
DEVICE: OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K123365(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 01-MAR-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNIGOLD GIARDIA
TRINITY BIOTECH                   510(k) NO: K120001(TRADITIONAL)
ATTN: LUPE  KAGAN                 PHONE NO : 760 929 0500   
5919 FARNSWORTH CT.               SE DECISION MADE: 01-MAR-13
CALIFORNIA CA 92008               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
BAXTER HEALTHCARE CORP.           510(k) NO: K130245(SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 224 270 3312   
32650 N WILSON RD.                SE DECISION MADE: 01-MAR-13
ROUND LAKE IL 60073 0490          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVOLUTION BILIARY STENT SYSTEM
COOK IRELAND LTD                  510(k) NO: K121430(TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 353 613 34440
O HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 01-MAR-13
LIMERICK    IE 000                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
DEPUY ORTHOPAEDICS                510(k) NO: K123924(TRADITIONAL)
ATTN: CORRENE  RAMY               PHONE NO : 574 371 4981   
700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 01-MAR-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
ORPHEUS MEDICAL, LTD.             510(k) NO: K123426(TRADITIONAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
11925 WEST I-70 FRONTAGE RD. STE 9SE DECISION MADE: 01-MAR-13
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITA ENAMIC STAINS
INNOVATION MEDITECH GMBH          510(k) NO: K123761(TRADITIONAL)
ATTN: ELIZABETH  WOLFSEN          PHONE NO : 714 961 6200   
3150 E. BIRCH ST.                 SE DECISION MADE: 01-MAR-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123812(TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 602 8157   
4040 NELSON AVE.                  SE DECISION MADE: 01-MAR-13
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIQUID ASSAYED MULTIQUAL PREMIUM
BIO-RAD LABORATORIES              510(k) NO: K130162(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 01-MAR-13
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERTEX THERMOSENS RIGID
VERTEX-DENTAL B.V.                510(k) NO: K123220(TRADITIONAL)
ATTN: MASON  DIAMOND              PHONE NO : 603 369 3550   
154 MAIN ST.                      SE DECISION MADE: 01-MAR-13
CHARLESTOWN NH 03603              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
TERUMO MEDICAL CORPORATION        510(k) NO: K122590(SPECIAL)
ATTN: STACY A KLUESNER, MS, RAC   PHONE NO : 732 302 4900   
265 DAVIDSON AVE, STE 320         SE DECISION MADE: 01-MAR-13
SOMERSET NJ 08873                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
MEDICA CORP.                      510(k) NO: K123802(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 01-MAR-13
BEDFORD MA 01730                  510(k) STATEMENT
 
DEVICE: REXTAR, REXTAR LCD
META BIOMED, INC.                 510(k) NO: K122016(TRADITIONAL)
ATTN: BLIX  WINSTON               PHONE NO : 301 607 9185   
2600 MULLINIX MILL ROAD           SE DECISION MADE: 01-MAR-13
MT. AIRY MD 21771                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
WRIGHT HEALTH GROUP LTD.          510(k) NO: K122955(ABBREVIATED)
ATTN: STEPHEN T MLCOCH            PHONE NO : 631 744 0059   
30 NORTHPORT ROAD                 SE DECISION MADE: 01-MAR-13
SOUND BEACH NY 11764              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ILAB ULTRASOUND IMAGING SYSTEM
BOSTON SCIENTIFIC CORP.           510(k) NO: K130243(SPECIAL)
ATTN: LORI R SMITH                PHONE NO : 510 624 1698   
47215 LAKEVIEW BLVD               SE DECISION MADE: 01-MAR-13
FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TM ARDIS INTERBODY SYSTEM INSERTER
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K123602(TRADITIONAL)
ATTN: JUDITH  ROSEN               PHONE NO : 973 576 0032   
10 POMEROY RD.                    SE DECISION MADE: 01-MAR-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRANSTEK BLOOD PRESSURE MONITOR
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K123780(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 01-MAR-13
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K123749(TRADITIONAL)
ATTN: CHO  SOW FONG               PHONE NO : 603 339276 16
LOT 16632, 5 1/4 MILES, JALAN MERUSE DECISION MADE: 01-MAR-13
SELANGOR DARUL EHSAN    MY 41050  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
COLOPLAST A/S                     510(k) NO: K123675(TRADITIONAL)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302 4987   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 01-MAR-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE
SCION MEDICAL TECHNOLOGIES LLC    510(k) NO: K123606(SPECIAL)
ATTN: JOSEPH  OSTENDORF           PHONE NO : 503 784 6756   
23879 BLUE SPRUCE RD              SE DECISION MADE: 01-MAR-13
SAUK CENTRE MN 56378              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAGNETOM ESSENZA WITH SYNGO MR D14
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130262(SPECIAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 01-MAR-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K130155(SPECIAL)
ATTN: KRISTIN  PABST              PHONE NO : 414 721 3104   
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 01-MAR-13
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UCENTUM
ULRICH GMBH & CO. KG              510(k) NO: K123717(TRADITIONAL)
ATTN: HANS  STOVER                PHONE NO : 636 519 0268   
612 TRADE CENTER BLVD             SE DECISION MADE: 04-MAR-13
CHESTERFIELD MO 63005             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACLEARA, THERACLEAR
THERAVANT CORPORATION             510(k) NO: K123889(TRADITIONAL)
ATTN: MARCY  MOORE                PHONE NO : 919 363 2432   
131 KELEKENT LANE                 SE DECISION MADE: 04-MAR-13
CARY NC 27518                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: URSA ANGIOGRAPHIC CATHETER
CURATIVE MEDICAL TECHNOLOGY, INC. 510(k) NO: K123818(SPECIAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
6518 TAMARIND SKY LANE            SE DECISION MADE: 04-MAR-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INBONE ( I AND II) TOTAL ANKLE SYSTEMS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K123059(TRADITIONAL)
ATTN: RYAN  BORMANN               PHONE NO : 901 867 4409   
5677 AIRLINE RD.                  SE DECISION MADE: 04-MAR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CURA COLLIMATOR
CURA MEDICAL TECHNOLOGIES, LLC    510(k) NO: K123893(TRADITIONAL)
ATTN: THOMAS H FARIS              PHONE NO : 650 996 1192   
23 RANCHO CIRCLE                  SE DECISION MADE: 04-MAR-13
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AVENIR MULLER STEM
ZIMMER GMBH                       510(k) NO: K123392(TRADITIONAL)
ATTN: KAREN  O'LEARY              PHONE NO : 574 371 8515   
P.O. BOX 708                      SE DECISION MADE: 04-MAR-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
DORNOCH MEDICAL SYSTEMS, INC.     510(k) NO: K123188(SPECIAL)
ATTN: LARRY  SMITH                PHONE NO : 816 505 2226   
200 Nw Parkway Rd                 SE DECISION MADE: 04-MAR-13
RIVERSIDE MO 64150                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
CELONOVA  BIOSCIENCES, INC.       510(k) NO: K130307(SPECIAL)
ATTN: NICOLE  BARBER              PHONE NO : 210 497 6682   
18615 TUSCANY STONE SUITE 100     SE DECISION MADE: 04-MAR-13
SAN ANTONIO TX 78258              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRASONIC SCALER
NAKANISHI, INC.                   510(k) NO: K113717(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DRIVE SUITE 280   SE DECISION MADE: 05-MAR-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FORTIVA PORCINE DERMIS
RTI BIOLOGICS, INC.               510(k) NO: K123356(TRADITIONAL)
ATTN: ESTHER  CARBON              PHONE NO : 386 418 8888   
11621 RESEARCH CIRCLE P.O. BOX 265SE DECISION MADE: 05-MAR-13
ALACHUA FL 32616 1627             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COLS® FIXATION SYSTEM
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K120740(SPECIAL)
ATTN: PATRICIA  DONNARD           PHONE NO : 332 985 59895
ZI DE KERNEVEZ-6 RUE NOBEL        SE DECISION MADE: 05-MAR-13
QUIMPER    FR 29000               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CALLISTO EYE
CARL ZEISS MEDITEC AG             510(k) NO: K123464(TRADITIONAL)
ATTN: JUDY  BRIMACOMBE            PHONE NO : 925 557 4616   
5160 HACIENDA DRIVE               SE DECISION MADE: 05-MAR-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CIMVA UNIVERSAL
THERAPEUTIC MONITORING SYSTEMS (TM510(k) NO: K123472(TRADITIONAL)
ATTN: CRAIG J COOMBS              PHONE NO : 510 337 0140   
1193 SHERMAN ST                   SE DECISION MADE: 05-MAR-13
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIDAS LYME IGG
BIOMERIEUX SA                     510(k) NO: K122986(TRADITIONAL)
ATTN: CATHERINE  FRITSCH          PHONE NO : 334 788723 98
CHEMIN DE L ORME                  SE DECISION MADE: 05-MAR-13
MARCY L ETOILE    FR 69280        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
MISONIX, INC.                     510(k) NO: K123980(SPECIAL)
ATTN: RONALD  MANNA               PHONE NO : 631 694 9555   
1938 NEW HIGHWAY                  SE DECISION MADE: 05-MAR-13
FARMINGDALE NY 11735              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DENTOCORE/DENTOCORE BODY
ITENA CLINICAL                    510(k) NO: K121769(ABBREVIATED)
ATTN: LOUIS- PAUL  MARIN          PHONE NO : 514 928 5576
500 BOUL CARTIER WEST             SE DECISION MADE: 05-MAR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUPERIOR LATERAL VARIAX CLAVICLE PLATE
STRYKER TRAUMA AG                 510(k) NO: K130116(SPECIAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 05-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTIPLE NAME
TOP CALIBRE SDN BHD               510(k) NO: K123819(TRADITIONAL)
ATTN: ROSNITA  MAODIN             PHONE NO : 603 329 10516
1-1,2 JALAN SETIA PRIMA U13/S SETISE DECISION MADE: 05-MAR-13
SHAH ALAM, SELANGOR    MY 40170   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K123837(SPECIAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 05-MAR-13
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JMS SAFE WING CATH (SWC)
JMS NORTH AMERICA CORPORATION     510(k) NO: K121488(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 05-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K123993(TRADITIONAL)
ATTN: TREVOR  DENBO               PHONE NO : 760 494 6951   
5818 EL CAMINO REAL               SE DECISION MADE: 05-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESTORELLE Y CONTOUR
COLOPLAST A/S                     510(k) NO: K123914(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4922   
1601 WEST RIVER ROAD N            SE DECISION MADE: 05-MAR-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOMONDE LARVAE
BIOMONDE (A TRADING NAME OF ZOOBIO510(k) NO: K123449(TRADITIONAL)
ATTN: ROSINA  ROBINSON RN, MED, RAPHONE NO : 508 597 6000   
225 TURNPIKE ROAD                 SE DECISION MADE: 05-MAR-13
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
PHILIPS MEDICAL SYSTEMS           510(k) NO: K120815(TRADITIONAL)
ATTN: PETER  SCHIPELLITI          PHONE NO : 978 687 1501   
3000 MINUTEMAN RD.                SE DECISION MADE: 06-MAR-13
ANDOVER MA 01810 1099             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KANGAROO NASAL MASK
RESPIRONICS INC.                  510(k) NO: K122847(SPECIAL)
ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   
1001 Murry Ridge Lane             SE DECISION MADE: 06-MAR-13
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAUTILUS SPINAL SYSTEM
LIFE SPINE                        510(k) NO: K123373(TRADITIONAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 Hassell Rd Ste 1535          SE DECISION MADE: 06-MAR-13
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARED UNDER GRAFTON II EDBM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122513(TRADITIONAL)
ATTN: KELLY  ANGLIN               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 06-MAR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LITTLE ANGELS SWADDLING BLANKET
BIONIX DEVELOPMENT CORP.          510(k) NO: K123411(TRADITIONAL)
ATTN: JAMES  HUTTNER              PHONE NO : 419 727 8421   
5154 ENTERPRISE BLVD.             SE DECISION MADE: 07-MAR-13
TOLEDO OH 43612                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
NXSTAGE MEDICAL, INC.             510(k) NO: K123395(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
350 Merrimack St                  SE DECISION MADE: 07-MAR-13
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
MACLIN POWER INC.                 510(k) NO: K121511(TRADITIONAL)
ATTN: ENRICO  BISSON              PHONE NO : 39 049 8630080
VIA MARZIA, 9                     SE DECISION MADE: 07-MAR-13
ABANO TERME, PD    IT 35031       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K122476(TRADITIONAL)
ATTN: DONNA  DI GANGI             PHONE NO : 805 541 3344   
4 LOS VERDES DRIVE                SE DECISION MADE: 07-MAR-13
SAN LUIS OBISPO CA 93401          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SAM JUNCTIONAL TOURNIQUET
SAM MEDICAL PRODUCTS              510(k) NO: K123694(TRADITIONAL)
ATTN: JACK N MCCUTCHEON           PHONE NO : 503 639 5474   
27350 SW 95th Ave Ste 3038 Bldg 30SE DECISION MADE: 07-MAR-13
Wilsonville OR 97070              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ECLIPSE SOFT TISSUE FASTENER
MEDSHAPE, INC                     510(k) NO: K123350(TRADITIONAL)
ATTN: JACK C GRIFFIS III          PHONE NO : 678 235 3311   
1575 NORTHSIDE DRIVE, SUITE 440   SE DECISION MADE: 07-MAR-13
ATLANTA GA 30318                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K123677(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   
500 GBC DRIVE M/S 514             SE DECISION MADE: 07-MAR-13
NEWARK DE 19702                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENESIS HEALTH RECORD SYSTEM, (GHRS)
GENESIS HEALTH TECHNOLOGIES       510(k) NO: K123136(TRADITIONAL)
ATTN: KATHLEEN  JOHNSON           PHONE NO : 641 472 0775   
P.O. OX 2042                      SE DECISION MADE: 07-MAR-13
FAIRFIELD IA 52556                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HERO GRAFT
HEMOSHPERE, INC., A CRYOLIFE COMPA510(k) NO: K124039(TRADITIONAL)
ATTN: LAURIE  LYNCH               PHONE NO : 952 582 6909   
6545 CITY WEST PARKWAY            SE DECISION MADE: 07-MAR-13
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
MICRO THERAPEUTICS, INC D/B/A: EV3510(k) NO: K124007(TRADITIONAL)
ATTN: ANALIA  STAUBLY             PHONE NO : 949 680 1201   
9775 TOLEDO WAY                   SE DECISION MADE: 07-MAR-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVRF SYSTEM
F CARE SYSTEMS NV                 510(k) NO: K130283(TRADITIONAL)
ATTN: E. J SMITH                  PHONE NO : 410 451 0639   
1468 HARWELL AVE                  SE DECISION MADE: 07-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
AAP BIOMATERIALS GMBH & CO. KG    510(k) NO: K123081(ABBREVIATED)
ATTN: VOLKER  STIRNAL             PHONE NO : 496 07 1929220
LAGERSTRASSE 11-15                SE DECISION MADE: 07-MAR-13
DIEBURG    GM 64807               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHUNTCHECK
NEURODX DEVELOPMENT LLC           510(k) NO: K123554(TRADITIONAL)
ATTN: FREDERICK J FRITZ           PHONE NO : 609 865 4426   
3333 Street Rd Suite 210          SE DECISION MADE: 07-MAR-13
Bensalem PA 19020                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
KAWASUMI LABORATORIES, INC.       510(k) NO: K123344(TRADITIONAL)
ATTN: CHRISTINA  HENZA            PHONE NO : 262 842 1257   
7401 104TH AVE. STE 160           SE DECISION MADE: 07-MAR-13
KENOSHA WI 53142                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP.                      510(k) NO: K122189(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 08-MAR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
BIOSPACE CORPORATION LIMITED      510(k) NO: K123228(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 08-MAR-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POLARIS 100/200
DRAGER MEDICAL GMBH               510(k) NO: K123776(ABBREVIATED)
ATTN: BETH  ZIS                   PHONE NO : 978 379 8255   
6 TECH DRIVE                      SE DECISION MADE: 08-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
PHILOSYS CO. LTD                  510(k) NO: K113636(TRADITIONAL)
ATTN: LINDA  CHAN                 PHONE NO : 646 454 5401   
304 PARK AVENUE SOUTH SUITE 218   SE DECISION MADE: 08-MAR-13
NEW YORK NY 10010                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
ASAHI INTECC CO., LTD.            510(k) NO: K122468(SPECIAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL SUITE 210           SE DECISION MADE: 08-MAR-13
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
ASAHI INTECC CO., LTD.            510(k) NO: K122469(SPECIAL)
ATTN: YOSHI  TERAI                PHONE NO : 949 756 8252   
2500 RED HILL AVE, SUITE 210      SE DECISION MADE: 08-MAR-13
SANTA ANA CA 92705                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FASTPACK CONTROL KIT
QUALIGEN, INC.                    510(k) NO: K123725(TRADITIONAL)
ATTN: MICHAEL  POIRIER            PHONE NO : 760 918 9165   
2042 CORTE DEL NOGAL              SE DECISION MADE: 08-MAR-13
CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: UNI-PICC
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K130034(TRADITIONAL)
ATTN: NOLA  BENSTOG               PHONE NO : 801 773 7798   
803 N. 1250 W. SUITE 1            SE DECISION MADE: 08-MAR-13
CENTERVILLE UT 84014              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORAVAN OSA
NEW JERSEY SNORING SOLUTIONS      510(k) NO: K121285(TRADITIONAL)
ATTN: DEBORAH  STEIN              PHONE NO : 973 736 0111   
769 NORTHFIELD AVENUE SUITE 154   SE DECISION MADE: 08-MAR-13
WEST ORANGE NJ 07052              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
QUIDEL CORP.                      510(k) NO: K123998(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 08-MAR-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMAGE WORKS PANOURA
MIC INTERNATIONAL                 510(k) NO: K122806(TRADITIONAL)
ATTN: IZUMI  MARUO                PHONE NO : 813 38 188577
4-1-17 HONGO BUNKYO-KU            SE DECISION MADE: 08-MAR-13
TOKYO    JA 113-0033              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNOVIS COLLAGEN MATRIX (TBD)
SYNOVIS SURGICAL INNOVATIONS      510(k) NO: K122306(TRADITIONAL)
ATTN: JODI  JORGENSON             PHONE NO : 651 736 7399   
2575 UNIVERSITY AVE. WEST         SE DECISION MADE: 08-MAR-13
ST. PAUL MN 55114 1024            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOSEE MODEL 8000 U-SCOPE
ENDOSEE CORP                      510(k) NO: K123151(TRADITIONAL)
ATTN: XIAOLONG(BRUCE)  OUYANG     PHONE NO : 650 397 5174   
4546 EL CAMINO REAL, SUITE 215    SE DECISION MADE: 08-MAR-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
ETHICON ENDO-SURGERY, LLC         510(k) NO: K123212(TRADITIONAL)
ATTN: LIPING  WU                  PHONE NO : 513 337 3135   
4545 CREEK ROAD                   SE DECISION MADE: 08-MAR-13
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
LIFE TECHNOLOGIES CORPORATION     510(k) NO: K123955(TRADITIONAL)
ATTN: DEANNA  VELLA               PHONE NO : 760 918 3000   
5791 VAN ALLEN WAY                SE DECISION MADE: 08-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REVOIS IMPLANT SYSTEM
RIEMSER ARZNEIMITTEL AG           510(k) NO: K113042(SPECIAL)
ATTN: JAMES M CLINTON             PHONE NO : 919 247 0479   
5105 FAIRROADS RD.                SE DECISION MADE: 08-MAR-13
DURHAM NC 27712                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRINITY ACETABULAR SYSTEM
CORIN MEDICAL                     510(k) NO: K130128(SPECIAL)
ATTN: LUCINDA  GERBER             PHONE NO : 813 977 4469   
5670 W. CYPRESS STREET SUITE C    SE DECISION MADE: 08-MAR-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GSO GS1 CANNULATED SCREW SYSTEM
GOLD STANDARD ORTHOPAEDICS, LLC   510(k) NO: K123487(TRADITIONAL)
ATTN: DAVID  BAUGHMAN             PHONE NO : 502 581 8770   
1226 ROWAN ST.                    SE DECISION MADE: 11-MAR-13
LOUISVILLE KY 40203               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISCOVERY TMAX MANUAL WHEELCHAIR
OTTO BOCK HEALTHCARE, LP          510(k) NO: K113164(TRADITIONAL)
ATTN: WILLIAM  KABITZ             PHONE NO : 763 553 9464   
2 CARLSON PKWY. N., SUITE 100     SE DECISION MADE: 11-MAR-13
MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AAP RADIUS SET 2.5
AAP IMPLANTATE AG                 510(k) NO: K123875(TRADITIONAL)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 49 307501 9193
LORENZWEG 5                       SE DECISION MADE: 11-MAR-13
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CS-MAG II
BIOMAGNETIK-PARK GMBH             510(k) NO: K121825(TRADITIONAL)
ATTN: THOMAS  WEBER               PHONE NO : 49 40 4710360
BEIM STROHHAUSE 27                SE DECISION MADE: 11-MAR-13
HAMBURG    GM 20097               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SILEX SACROILIAC JOINT FUSION SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K123702(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN, M.D.      PHONE NO : 937 847 8400   
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 11-MAR-13
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K123073(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 52 28516789
Building 6 and 7, Zhu Keng IndustrSE DECISION MADE: 11-MAR-13
Shenzhen    CN 518118             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
TRUDELL MEDICAL INTL.             510(k) NO: K123614(TRADITIONAL)
ATTN: DARRYL  FISCHER             PHONE NO : 519 455 7060
725 THIRD ST.                     SE DECISION MADE: 11-MAR-13
LONDON    CA N5V 5G4              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K123815(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
911 HANSEN WAY                    SE DECISION MADE: 11-MAR-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PICCOLO LACTATE TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K130113(TRADITIONAL)
ATTN: DENNIS M BLEILE             PHONE NO : 510 675 6515   
3240 WHIPPLE RD.                  SE DECISION MADE: 11-MAR-13
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GYNECOLOGY STERILIZATION TRAY
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K121904(TRADITIONAL)
ATTN: JANICE  HASELTON            PHONE NO : 978 749 1494   
150 Minuteman Rd                  SE DECISION MADE: 11-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DX-D IMAGING PACKAGE
AGFA HEALTHCARE N.V.              510(k) NO: K122736(TRADITIONAL)
ATTN: DAVID  LEDWIG               PHONE NO : 828 862 8555   
PO BOX 1927                       SE DECISION MADE: 11-MAR-13
BREVARD NC 28712                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STEREOS WORKSTATION
EOS IMAGING INC.                  510(k) NO: K130395(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH ST, NW             SE DECISION MADE: 11-MAR-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
PHILIPS MEDICAL SYSTEMS           510(k) NO: K130153(TRADITIONAL)
ATTN: MARK  PUOPOLO               PHONE NO : 978 659 4244   
3000 Minuteman Rd                 SE DECISION MADE: 12-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOPROCARE
SOPRO                             510(k) NO: K121685(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 856 222 9988   
124 GAITHER DRIVE SUITE 140       SE DECISION MADE: 12-MAR-13
MT. LAUREL NJ 08054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEMORY METAL STAPLES, EASYCLIP
STRYKER CORP.                     510(k) NO: K122113(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 5718   
325 CORPORATE DRIVE               SE DECISION MADE: 12-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS, INC.    510(k) NO: K123939(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PWKY.              SE DECISION MADE: 12-MAR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IODOFOAM IODOPHOR FOAM DRESSING
PROGRESSIVE WOUNDCARE TECHNOLOGIES510(k) NO: K122634(TRADITIONAL)
ATTN: MASON  DIAMOND              PHONE NO : 508 333 0108   
150 LEVINBERG LANE                SE DECISION MADE: 12-MAR-13
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNGO, CT BONE READING
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123584(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 12-MAR-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PERKINELMER 226 SAMPLE COLLECTION DEVICES
PERKINELMER, INC.                 510(k) NO: K121864(ABBREVIATED)
ATTN: KAY A TAYLOR                PHONE NO : 317 418 1735   
17 P&N DRIVE                      SE DECISION MADE: 12-MAR-13
GREENVILLE SC 29611               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER NEXEL TOTAL ELBOW
ZIMMER, INC.                      510(k) NO: K123862(TRADITIONAL)
ATTN: JOANNA L SURMA              PHONE NO : 574 371 1642   
1800 WEST CENTER STREET           SE DECISION MADE: 12-MAR-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GETINGE 400HC-E / SERIES STEAM STERILIZER
GETINGE SOURCING LLC              510(k) NO: K122071(TRADITIONAL)
ATTN: BARB  SMITH                 PHONE NO : 585 214 6049   
1777 EAST HENRIETTA RD.           SE DECISION MADE: 12-MAR-13
ROCHESTER NY 14623 3133           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
RAYENCE CO., LTD                  510(k) NO: K123345(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 12-MAR-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAYSCAN A-EXPERT 3D
RAY CO., LTD                      510(k) NO: K122981(TRADITIONAL)
ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000   
8920 WILSHIRE BLVD SUITE 603      SE DECISION MADE: 12-MAR-13
BEVERLY HILLS CA 90211            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
TERUMO CORPORATION                510(k) NO: K130493(SPECIAL)
ATTN: GARRY A COURTNEY, MBA, RAC  PHONE NO : 800 283 7866   
125 BLUE BALL ROAD                SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VISIOFOCUS
TECNIMED S.R.L.                   510(k) NO: K122412(SPECIAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 2630   
110 E. GRANADA BLVD SUITE 209     SE DECISION MADE: 13-MAR-13
ORMOND BEACH FL 32176             510(k) STATEMENT
 
DEVICE: NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
NOBEL BIOCARE AB                  510(k) NO: K122602(TRADITIONAL)
ATTN: PHUONG  NGUYEN SON          PHONE NO : 714 282 4800   
22715 SAVI RANCH PKWY.            SE DECISION MADE: 13-MAR-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ESOPHAGUS BOUGIE SET
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K130251(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
911 HANSEN WAY                    SE DECISION MADE: 13-MAR-13
PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123370(TRADITIONAL)
ATTN: KAREN  JONES                PHONE NO : 801 565 6231   
12050 LONE PEAK PKWY              SE DECISION MADE: 13-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUVON VITALS CHARTING SYSTEM
NUVON, INC.                       510(k) NO: K130234(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH STREET NW          SE DECISION MADE: 13-MAR-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOGENESIS IMPLANT SYSTEM
LK CONSULTING GROUP               510(k) NO: K120089(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 13-MAR-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSIGNIA WITH ITERO
ORMCO CORP.                       510(k) NO: K123416(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 13-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
ASHITAKA FACTORY OF TERUMO CORP.  510(k) NO: K130520(SPECIAL)
ATTN: EILEEN  DORSEY              PHONE NO : 800 262 3304   
150 MAIMAIGI-CHO                  SE DECISION MADE: 13-MAR-13
FUJINOMIYA, SHIZUOKA    JA 418-001510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PULMOSAL
PHARMACARIBE                      510(k) NO: K130091(SPECIAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 13-MAR-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
CARTICEPT MEDICAL, INC.           510(k) NO: K124053(SPECIAL)
ATTN: TANYA  EBERLE               PHONE NO : 770 754 3800   
6120 Windward Pkwy Ste 220        SE DECISION MADE: 13-MAR-13
Alpharetta GA 30005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
PHADIA AB                         510(k) NO: K121156(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVENUE            SE DECISION MADE: 13-MAR-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORALID
FORWARD SCIENCE LLC               510(k) NO: K123169(TRADITIONAL)
ATTN: BRIAN  PIKKULA              PHONE NO : 855 696 7254   
2511 WIND FALL LN                 SE DECISION MADE: 13-MAR-13
SUGAR LAND TX 77479               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPTIMA MR450W
GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K123522(TRADITIONAL)
ATTN: MICHELLE  HUETTNER          PHONE NO : 262 521 6102   
3200 N. GRANDVIEW BLVD            SE DECISION MADE: 13-MAR-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
TERUMO CORPORATION                510(k) NO: K130280(SPECIAL)
ATTN: GARRY A COURTNEY, MBA, RAC  PHONE NO : 800 283 7866   
125 BLUE BALL ROAD                SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K130333(SPECIAL)
ATTN: SUZANNE  GRENIER            PHONE NO : 800 262 3304   
125 BLUE BALL RD.                 SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K130359(SPECIAL)
ATTN: SUZANNE  GRENIER            PHONE NO : 800 262 3304   
125 BLUE BALL RD.                 SE DECISION MADE: 13-MAR-13
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: K SERIES CPAP SYSTEMS
CURATIVE MEDICAL INC.             510(k) NO: K123897(SPECIAL)
ATTN: AMY  MCKINNEY               PHONE NO : 979 236 1622   
6518 TAMARIND SKY LN.             SE DECISION MADE: 13-MAR-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STA- COAG CONTROL (N+ABN) PLUS
DIAGNOSTICA STAGO, INC.           510(k) NO: K120014(TRADITIONAL)
ATTN: KEVIN  WYCKOFF              PHONE NO : 973 631 1200   
5 CENTURY DR.                     SE DECISION MADE: 14-MAR-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K122534(ABBREVIATED)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVE.                 SE DECISION MADE: 14-MAR-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYCARE ONLINE
RESMED LTD.                       510(k) NO: K123557(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 14-MAR-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
POLYMED THERAPEUTICS, INC         510(k) NO: K122907(TRADITIONAL)
ATTN: FENG-YU  LEE                PHONE NO : 949 951 3046   
27001 LA PAZ ROAD, SUITE 266B     SE DECISION MADE: 14-MAR-13
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CATALYST II AND III
CARDIVA MEDICAL, INC.             510(k) NO: K130124(TRADITIONAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 925 254 5228   
8 SNOWBERRY CT.                   SE DECISION MADE: 14-MAR-13
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERSAPORT V2 BLADELESS OPTICAL TROCAR
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K130435(SPECIAL)
ATTN: SARAH  RIZK                 PHONE NO : 203 492 5493   
60 Middletown Ave                 SE DECISION MADE: 14-MAR-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHINA NAILS AND ACCESSORIES
SMITH & NEPHEW, INC.              510(k) NO: K123948(TRADITIONAL)
ATTN: JASON  SELLS                PHONE NO : 901 399 5520   
1450 BROOKS RD.                   SE DECISION MADE: 14-MAR-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
SMARTGUARD, INC.                  510(k) NO: K123161(TRADITIONAL)
ATTN: SHELLY  GARG                PHONE NO : 305 372 2421   
601 BRICKELL KEY DRIVE SUITE 104  SE DECISION MADE: 14-MAR-13
MIAMI FL 33131                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
GLOBUS MEDICAL, INC.              510(k) NO: K123783(TRADITIONAL)
ATTN: SARAH M FITZGERALD          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 14-MAR-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
MARVAO MEDICAL DEVICES, LTD.      510(k) NO: K121933(TRADITIONAL)
ATTN: MARYBETH  GAMBER            PHONE NO : 508 351 8632   
368 WEST MAIN STREET SUITE 7      SE DECISION MADE: 14-MAR-13
NORTHBOROUGH MA 01532             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NIDEK RS-3000
NIDEK CO., LTD.                   510(k) NO: K121622(TRADITIONAL)
ATTN: LENA  SATTLER               PHONE NO : 440 554 3706   
1667 RIDGEWOOD RD                 SE DECISION MADE: 14-MAR-13
WADSWORTH OH 44281                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
CALGARY SCIENTIFIC, INC.          510(k) NO: K123186(TRADITIONAL)
ATTN: KYLE  PETERSON              PHONE NO : 403 767 7945
SUITE 208, 1210 20TH AVENUE SE    SE DECISION MADE: 14-MAR-13
CALGARY, ALBERTA    CA T2G 1M8    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PARAGON HIP SYSTEM
GLOBAL MANUFACTURING TECHNOLOGY   510(k) NO: K123782(TRADITIONAL)
ATTN: HOLLACE S RHODES            PHONE NO : 202 552 5800   
1331 H STREET NW                  SE DECISION MADE: 14-MAR-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BEGOPAL+
BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K123929(ABBREVIATED)
ATTN: HEIKE  GUSTKE               PHONE NO : 49 421202 8112
WILHELM-HERBST-STRASSE 1          SE DECISION MADE: 14-MAR-13
BREMEN    GM 28359                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K123933(TRADITIONAL)
ATTN: ELISABETH  WARRINER         PHONE NO : 916 374 3244   
1584 ENTERPRISE BLVD.             SE DECISION MADE: 14-MAR-13
WEST SACRAMENTO CA 95691          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
INTERSURGICAL INCORPORATED        510(k) NO: K121747(TRADITIONAL)
ATTN: MICHAEL  ZALEWSKI           PHONE NO : 315 451 2900   
417 ELECTRONICS PARKWAY           SE DECISION MADE: 14-MAR-13
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
PIVOT MEDICAL INC.                510(k) NO: K130351(SPECIAL)
ATTN: JON  COOK                   PHONE NO : 408 774 1452   
247 HUMBOLDT CT                   SE DECISION MADE: 14-MAR-13
SUNNYVALE CA 94089 0000           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
RADIOMETER MEDICAL APS            510(k) NO: K130236(TRADITIONAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 3827 3114
AKANDEVEJ 21                      SE DECISION MADE: 15-MAR-13
BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: X-FIX DYNAMIC EXTERNAL DISTRACTOR
AREX USA LLC                      510(k) NO: K122415(TRADITIONAL)
ATTN: CHARLES  HOKANSON           PHONE NO : 610 715 3263   
1709 HILL ST.                     SE DECISION MADE: 15-MAR-13
EDGEWATER FL 32132                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRASONIC NEBULIZER (MESH TYPE)
K-JUMP HEALTH CO., LTD.           510(k) NO: K121520(ABBREVIATED)
ATTN: JM  LIN                     PHONE NO : 886 2 22991378
NO. 56, WU KUNG 5TH RD., NEW TAIPESE DECISION MADE: 15-MAR-13
NEW TAIPEI    TW 24890            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAYSCAN A-EXPERT
RAY CO., LTD                      510(k) NO: K122918(TRADITIONAL)
ATTN: ANDREW  PAENG               PHONE NO : 317 363 1000   
8920 WILSHIRE BLLVD SUITE 603     SE DECISION MADE: 15-MAR-13
BEVERLY HILLS CA 90211            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK
3M COMPANY                        510(k) NO: K121593(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 15-MAR-13
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123298(TRADITIONAL)
ATTN: DANNETTE  CROOMS            PHONE NO : 801 565 6209   
12050 LONE PEAK PKWY              SE DECISION MADE: 15-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLIXENE IFG VASCULAR GRAFT
ATRIUM MEDICAL CORPORATION        510(k) NO: K130142(TRADITIONAL)
ATTN: MEGAN  MCCAGH, RAC, CTBS    PHONE NO : 603 880 1436   
5 WENTWORTH DR                    SE DECISION MADE: 15-MAR-13
HUDSON NH 03051                   510(k) STATEMENT
 
DEVICE: BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
AAP BIOMATERIALS GMBH & CO. KG    510(k) NO: K123225(ABBREVIATED)
ATTN: VOLKER  STIRNAL             PHONE NO : 49 607 1929220
LAGERSTRASSE 11-15                SE DECISION MADE: 15-MAR-13
DIEBURG    GM 64807               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TVC IMAGING SYSTEM MODEL NIRS-MC7-70
INFRAREDX, INC.                   510(k) NO: K123108(TRADITIONAL)
ATTN: STEVEN J CHARTIER           PHONE NO : 781 221 0053   
34 Third Avenue                   SE DECISION MADE: 15-MAR-13
Burlington MA 01803               510(k) STATEMENT
 
DEVICE: GALILEOS FAMILY
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123070(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251163 294
FABRIKSTRASSE 31                  SE DECISION MADE: 15-MAR-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDELA THOPAZ
MEDELA AG                         510(k) NO: K130210(TRADITIONAL)
ATTN: MARKUS  BUETLER             PHONE NO : 041 769515 1247
LAETTICHSTRASSE 4B                SE DECISION MADE: 15-MAR-13
BAAR, ZUG    SZ CH-6341           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
ROCHE DIAGNOSTICS CORP.           510(k) NO: K130138(SPECIAL)
ATTN: JUSTIN  DAVIS               PHONE NO : 317 521 6204   
9115 HAGUE RD.                    SE DECISION MADE: 15-MAR-13
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
BIOMET SPORTS MEDICINE            510(k) NO: K123485(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 371 1176   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 18-MAR-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
FILLIGENT LIMITED                 510(k) NO: K122702(TRADITIONAL)
ATTN: KAI  DEUSCH                 PHONE NO : 852 254224 00
7TH FLLOR, 69 JERVOIS STREET, SHEUSE DECISION MADE: 18-MAR-13
HONG KONG    CH HK                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3M ATTEST(TM) AUTO-READER
3M COMPANY                        510(k) NO: K123546(TRADITIONAL)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   
3M CENTER, BLDG. 275--05-W-06     SE DECISION MADE: 18-MAR-13
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STERILE LATEX SURGICAL GLOVE
LUCENXIA PRESCIENCE AG            510(k) NO: K123628(TRADITIONAL)
ATTN: ROBERT  HILL                PHONE NO : 41 417689 126
RATHAUSSTRASSE 7                  SE DECISION MADE: 18-MAR-13
BAAR    SZ 6341                   510(k) STATEMENT
 
DEVICE: LANX FUSION SYSTEM- SA
LANX, INC.                        510(k) NO: K123767(TRADITIONAL)
ATTN: ALAN  BURKHOLDER            PHONE NO : 303 443 7500   
310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 18-MAR-13
BROOMFIELD CO 80021               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
SMITH & NEPHEW, INC.              510(k) NO: K122059(TRADITIONAL)
ATTN: KARIN  DESJARDINS           PHONE NO : 508 337 4035   
150 MINUTEMAN RD.                 SE DECISION MADE: 18-MAR-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: URGOCLEAN ABSORBENT WOUND DRESSING
LABORATOIRES URGO                 510(k) NO: K123219(TRADITIONAL)
ATTN: SOPHIE  FORTIN              PHONE NO : 333 804428 78
EXCELLENCE 2000 2 AVENUE DE STRASBSE DECISION MADE: 18-MAR-13
CHEVIGNY SAINT SAUVEUR    FR 21801510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUMED CANNULATED SCREW SYSTEM
ACUMED LLC                        510(k) NO: K123890(TRADITIONAL)
ATTN: KARA  BUDOR                 PHONE NO : 503 207 1412   
5885 NW Cornelius Pass Rd         SE DECISION MADE: 18-MAR-13
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
MEDTRONIC PERFUSION SYSTEMS       510(k) NO: K123351(TRADITIONAL)
ATTN: JULIA A NELSON              PHONE NO : 763 514 9844   
7611 NORTHLAND DR.                SE DECISION MADE: 19-MAR-13
MINNEAPOLIS MN 55432              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
COOK, INC.                        510(k) NO: K122940(TRADITIONAL)
ATTN: ELYSIA  EASTON              PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 19-MAR-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IOGYN ENDOSCOPE
IOGYN, INC.                       510(k) NO: K123330(TRADITIONAL)
ATTN: MARY J EDWARDS              PHONE NO : 952 227 3394   
5353 WAYZATA BOULEVARD STE. 505   SE DECISION MADE: 19-MAR-13
MINNEAPOLIS MN 55416              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIA MICROCATHETER, VIA PLUS MICROCATHETER
SEQUENT MEDICAL, INC              510(k) NO: K123477(TRADITIONAL)
ATTN: MELANIE  PARRAVI            PHONE NO : 949 830 9600   
11A COLUMBIA                      SE DECISION MADE: 19-MAR-13
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORBIT INFUSION SET
YPSOMED AG                        510(k) NO: K130468(SPECIAL)
ATTN: BENJAMIN  REINMANN          PHONE NO : 41 34 4243117
BRUNNMATTSTRASSE 6                SE DECISION MADE: 19-MAR-13
BURGDORF    SZ CH-3401            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL RETINAL CAMERA
CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K123208(TRADITIONAL)
ATTN: IZUMI  MARUO                PHONE NO : 813 381885 77
4-1-17 HONGO                      SE DECISION MADE: 19-MAR-13
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
SOFLEX LIMITED                    510(k) NO: K122220(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 19-MAR-13
LITTLETON CO 80127                510(k) STATEMENT
 
DEVICE: DEUTOETCH QUICKBOND BOND ACTIRATOR
ITENA CLINICAL                    510(k) NO: K122522(TRADITIONAL)
ATTN: LOUIS-PAUL  MARIN           PHONE NO : 514 928 5546
500 BOUL CARTIER WEST             SE DECISION MADE: 19-MAR-13
LAVAL    CA H7V 5B7               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GUIDEZILLA GUIDE EXTENSION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K123765(TRADITIONAL)
ATTN: HOLLY  RAMIREZ              PHONE NO : 763 494 2113   
ONE SCIMED PLACE                  SE DECISION MADE: 19-MAR-13
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CADWELL DISPOSABLE PROBE HANDLE
CADWELL                           510(k) NO: K123589(TRADITIONAL)
ATTN: CHRIS  BOLKAN               PHONE NO : 509 735 6481   
909 N. KELLOGG ST.                SE DECISION MADE: 19-MAR-13
KENNEWICK WA 99336                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
BIODENTA SWISS AG                 510(k) NO: K123415(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174711 11
TRAMSTRASSE 16                    SE DECISION MADE: 19-MAR-13
BERNECK, ST.GALLEN    SZ 9442     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
AALTO SCIENTIFIC LTD.             510(k) NO: K130157(TRADITIONAL)
ATTN: DESSI  LYAKOV               PHONE NO : 760 431 6942   
1959 KELLOGG AVE.                 SE DECISION MADE: 19-MAR-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTERVENTIONAL HEMOSTATIC BANDAGE
Z-MEDICA CORPORATION              510(k) NO: K120782(TRADITIONAL)
ATTN: SHEILA  WALLIN              PHONE NO : 203 294 0000   
4 FAIRFIELD BLVD.                 SE DECISION MADE: 20-MAR-13
Wallingford CT 06492              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CEREC BLOCS C IN
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123952(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 49 625116 0
FABRIKSTRASSE 31                  SE DECISION MADE: 20-MAR-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PALM BLADDER SCANNER
MIANYANG MEIKE ELECTRONIC EQUIPMEN510(k) NO: K130229(ABBREVIATED)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182
ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 20-MAR-13
WENZHOU, ZHEJIANG    CH 325000    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
SORIN GROUP ITALIA S.R.L.         510(k) NO: K130433(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 20-MAR-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
PENTAX OF AMERICA, INC.           510(k) NO: K130247(SPECIAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 PARAGON DRIVE                   SE DECISION MADE: 20-MAR-13
MONTVALE NJ 07645                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
ST. JUDE MEDICAL                  510(k) NO: K130252(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 593 2960   
15900 VALLEY VIEW CT.             SE DECISION MADE: 20-MAR-13
SYLMAR CA 91342 3577              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
ST. JUDE MEDICAL                  510(k) NO: K130257(TRADITIONAL)
ATTN: COLLEEN  CANAN              PHONE NO : 818 493 2960   
15900 VALLEY VIEW CT.             SE DECISION MADE: 20-MAR-13
SYLMAR CA 91342 3577              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: E-Z CHEK BLOOD LEAK TEST STRIPS
REPROCESSING PRODUCTS CORP.       510(k) NO: K123805(TRADITIONAL)
ATTN: TED  WILLIAMS               PHONE NO : 520 888 5551   
P.O. BOX 35849                    SE DECISION MADE: 20-MAR-13
TUCSON AZ 85740                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIDCORAPID V2 MONITOR
LIDCO LTD.                        510(k) NO: K122247(TRADITIONAL)
ATTN: GREGORY  SPELLER            PHONE NO : 442 077 491500
16 ORSMAN RD.                     SE DECISION MADE: 20-MAR-13
LONDON    UK N15QJ                510(k) STATEMENT
 
DEVICE: OPTETRAK LOGIC POROUS FEMORAL COMPONENT
EXACTECH, INC.                    510(k) NO: K123687(TRADITIONAL)
ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 20-MAR-13
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MIRADA RTX
MIRADA MEDICAL LTD.               510(k) NO: K130393(TRADITIONAL)
ATTN: GWILYM  OWEN                PHONE NO : 440 186581 1172
OXFORD CENTRE FOR INNOVATION NEW RSE DECISION MADE: 20-MAR-13
OXFORD, OXFORDSHIRE    UK OX1 1BY 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TX1 TISSUE REMOVAL SYSTEM
TENEX HEALTH                      510(k) NO: K123640(TRADITIONAL)
ATTN: DAVID  SALZBERG             PHONE NO : 949 580 1266   
26902 VISTA TERRACE               SE DECISION MADE: 20-MAR-13
LAKE FOREST CA 92630              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUITEHEART
NEOSOFT, LLC                      510(k) NO: K130228(TRADITIONAL)
ATTN: JACKIE  SCHWABE             PHONE NO : 262 522 6120   
N27 W23910A PAUL RD.              SE DECISION MADE: 20-MAR-13
PEWAUKEE WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VANGUARD XP KNEE SYSTEM
BIOMET MANUFACTURING CORP.        510(k) NO: K122160(TRADITIONAL)
ATTN: TRACY  BICKEL JOHNSON       PHONE NO : 574 267 6639   
56 EAST BELL DRIVE                SE DECISION MADE: 20-MAR-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEMI ULTRA
KERR CORPORATION                  510(k) NO: K123468(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 20-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD ALCOHOL SWAB
BECTON DICKINSON & CO.            510(k) NO: K121655(TRADITIONAL)
ATTN: AVITAL  LAKES               PHONE NO : 201 847 4739   
1 BECTON DR.                      SE DECISION MADE: 20-MAR-13
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
STRYKER TRAUMA AG                 510(k) NO: K123403(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 20-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
PENTAX OF AMERICA, INC.           510(k) NO: K130206(SPECIAL)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 431 5880   
3 PARAGON DR.                     SE DECISION MADE: 20-MAR-13
MONTVALE NJ 07645 1782            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
THE ORTHOPAEDIC IMPLANT COMPANY (O510(k) NO: K123832(TRADITIONAL)
ATTN: ITAI  NEMOVICHER            PHONE NO : 775 636 8281   
316 CALIFORNIA AVE #701           SE DECISION MADE: 20-MAR-13
RENO NV 89509                     510(k) STATEMENT
 
DEVICE: HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
MEDIMECCA CO., LTD.               510(k) NO: K130221(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 21-MAR-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHENZHEN MED-LINK PULSE OXIMETER PROBE
SHENZHEN MED-LINK ELECTRONICS TECH510(k) NO: K113727(TRADITIONAL)
ATTN: RHONDA  ALEXANDER           PHONE NO : 757 224 0177   
144 RESEARCH DRIVE                SE DECISION MADE: 21-MAR-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BETA-TCP GRANULES
SKELETAL KINETICS, LLC            510(k) NO: K120354(TRADITIONAL)
ATTN: CHRISTINE  KUO              PHONE NO : 408 350 5242   
10201 BUBB RD.                    SE DECISION MADE: 21-MAR-13
CUPERTINO CA 95014 4167           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DORNIER MEDILAS UROPULSE
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K130344(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 21-MAR-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121772(ABBREVIATED)
ATTN: FRANS  JACOBS               PHONE NO : 31 40 2799709
VEENPLUIS 4-6                     SE DECISION MADE: 21-MAR-13
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUNRAY FETAL MONITOR
SUNRAY MEDICAL APPARATUS CO., LTD.510(k) NO: K123335(TRADITIONAL)
ATTN: SABRINA  WEI                PHONE NO : 86 7558 6329133
B102 NANSHAN MEDICAL DEVICES INDUSSE DECISION MADE: 21-MAR-13
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BP652N (HEM-6300-Z)
OMRON HEALTHCARE, INC.            510(k) NO: K123498(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 21-MAR-13
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130619(TRADITIONAL)
ATTN: SHELLY  PEARCE              PHONE NO : 
685 East Middlefield Road         SE DECISION MADE: 21-MAR-13
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CAPNO MODULE, 92517
SPACELABS HEALTHCARE              510(k) NO: K130112(SPECIAL)
ATTN: THOMAS  KROENKE             PHONE NO : 303 956 4232   
P.O. BOX 3018                     SE DECISION MADE: 21-MAR-13
NEDERLAND CO 80466                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVANCE TOTAL KNEE SYSTEM-PATELLA
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K122218(SPECIAL)
ATTN: DANIELLE  MUELLER           PHONE NO : 901 290 5904   
5677 AIRLINE RD.                  SE DECISION MADE: 21-MAR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PINPOINTE FOOTLASER
NUVOLASE, INC.                    510(k) NO: K130413(SPECIAL)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586 3113   
26 REBECCA CT                     SE DECISION MADE: 21-MAR-13
HOMOSASSA FL 34446                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VEEDA 100% COTTON MENSTRUAL TAMPON
NATURALENA BRANDS, INC.           510(k) NO: K130609(TRADITIONAL)
ATTN: JOSH  ELLIS                 PHONE NO : 435 238 4961   
1875 S. GRANT ST. SUITE 570       SE DECISION MADE: 21-MAR-13
SAN MATEO CA 94402                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PASS OCT SPINAL SYSTEM
MEDICREA INTERNATIONAL            510(k) NO: K121979(TRADITIONAL)
ATTN: LAURA  AVIRON-VIOLET        PHONE NO : 334 720 18787
14 Porte du Grand Lyon            SE DECISION MADE: 21-MAR-13
NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K121981(TRADITIONAL)
ATTN: PHILIP  LIU                 PHONE NO : 914 524 2443   
511 BENEDICT AVENUE               SE DECISION MADE: 21-MAR-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S9 VPAP TX
RESMED LTD.                       510(k) NO: K123511(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 21-MAR-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEVER TD-7001NEBULIZER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K122060(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 21-MAR-13
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GARAVENTA X3 INCLINED PLATFORM LIFT
GARAVENTA (CANADA) LTD [DBA GARAVE510(k) NO: K122206(SPECIAL)
ATTN: JAY  MANSOUR                PHONE NO : 678 908 8180   
845 ARONSON LAKE COURT            SE DECISION MADE: 21-MAR-13
ROSWELL GA 30075                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APPS-HEALTH01
ANDON HEALTH CO., LTD             510(k) NO: K122098(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 260 526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 21-MAR-13
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K121894(TRADITIONAL)
ATTN: LUBNA  SYED                 PHONE NO : 416 593 4323
439 UNIVERSITY AVE. Suite 900     SE DECISION MADE: 21-MAR-13
TORONTO    CA M5G 1Y8             510(k) STATEMENT
 
DEVICE: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC.             510(k) NO: K120771(ABBREVIATED)
ATTN: ERIC  GRACE                 PHONE NO : 305 380 2728   
11800 SW 147TH AVE.               SE DECISION MADE: 22-MAR-13
MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FEMORAL ACCESS VENOUS CANNULAE
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123303(TRADITIONAL)
ATTN: DANNETTE  CROOMS            PHONE NO : 801 565 6209   
12050 LONE PEAK PKWY              SE DECISION MADE: 22-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MRII CRAINIAL DRILL
MRI INTERVENTIONS, INC.           510(k) NO: K122456(TRADITIONAL)
ATTN: E.F.  WADDELL               PHONE NO : 949 900 6833   
5 Musick                          SE DECISION MADE: 22-MAR-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
SPINEOLOGY, INC.                  510(k) NO: K123652(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8500   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 22-MAR-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VARIAX 2 COMPRESSION PLATING SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K130009(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 22-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOSCOPIC INTRODUCER
NOVADAQ TECHNOLOGIES, INC.        510(k) NO: K123013(TRADITIONAL)
ATTN: TIM  VERSPAGEN              PHONE NO : 604 232 9861
13155 DELF PLACE, UNIT 250        SE DECISION MADE: 22-MAR-13
RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K130141(TRADITIONAL)
ATTN: ERIKA B AMMIRATI, RAC, MT (APHONE NO : 650 949 2768   
630 CLYDE COURT                   SE DECISION MADE: 22-MAR-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXIS-SHIELD ACVTIVE-B12
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K121946(TRADITIONAL)
ATTN: SIMON JOHN  RICHARDS        PHONE NO : 44 13 82422000
THE TECHNOLOGY PARK, LUNA PLACE   SE DECISION MADE: 22-MAR-13
DUNDEE, SCOTLAND    UK DD2 1XA    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K122037(TRADITIONAL)
ATTN: BECKY  RONNER               PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 22-MAR-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALCO-SCREEN
CHEMATICS, INC.                   510(k) NO: K121247(TRADITIONAL)
ATTN: CARL  REYNOLDS              PHONE NO : 513 265 6257   
P.O. BOX 293 HIGHWAY 13 SOUTH     SE DECISION MADE: 22-MAR-13
NORTH WEBSTER IN 46555            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
MEDTRONIC NAVIGATION, INC.        510(k) NO: K124004(TRADITIONAL)
ATTN: MICHAEL  BLASCO             PHONE NO : 720 890 3391   
826 COAL CREEK CIRCLE             SE DECISION MADE: 22-MAR-13
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIMENSION EXL WITH LM SYSTEM
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K130276(TRADITIONAL)
ATTN: PAMELA A JURGA              PHONE NO : 302 631 8891   
500 GBC DRIVE M/S 514 P.O. BOX 610SE DECISION MADE: 22-MAR-13
NEWARK DE 19714 3026              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEINE MINI 3000 LED OPHTHALMOSCOPE
HEINE OPTOTECHNIK GMBH & CO. KG.  510(k) NO: K123587(ABBREVIATED)
ATTN: JOERG  ROENNAU              PHONE NO : 49 8152 38269
KIENTALSTRASSE 7                  SE DECISION MADE: 22-MAR-13
HERRSCHING    GM D-82211          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PROCARE MONITOR B20
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K122253(SPECIAL)
ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063   
8200 WEST TOWER AVE               SE DECISION MADE: 22-MAR-13
MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BALANCED KNEE SYSTEM HIGH FLEX PS
ORTHO DEVELOPMENT CORP.           510(k) NO: K123457(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 22-MAR-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MORTARA SURVEYOR PATIENT MONITOR
MORTARA INSTRUMENT, INC.          510(k) NO: K123556(ABBREVIATED)
ATTN: AMY  YANG                   PHONE NO : 414 354 1600   
7865 NORTH 86TH ST.               SE DECISION MADE: 22-MAR-13
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAIMAN SEAL AND CUT TECHNOLOGY
AESCULAP, INC.                    510(k) NO: K130596(SPECIAL)
ATTN: DENISE  ADAMS               PHONE NO : 610 984 9076   
3773 CORPORATE PARKWAY            SE DECISION MADE: 22-MAR-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FIBERLASE ENDURE CO2 FIBER
LUMENIS LTD.                      510(k) NO: K130164(SPECIAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 4 6388837
31 HAAVODA ST.                    SE DECISION MADE: 24-MAR-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXERA 2 ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K123618(TRADITIONAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 261 8073   
740 Bay Rd                        SE DECISION MADE: 24-MAR-13
Redwood City CA 94063             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEMOSIL READIPLAS TIN
INSTRUMENTATION LABORATORY CO.    510(k) NO: K122584(TRADITIONAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4350   
180 HARTWELL ROAD                 SE DECISION MADE: 24-MAR-13
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRO-DENSE BONE GRAFT SUBSTITUTE
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K113871(TRADITIONAL)
ATTN: SAMIR  IBRAHIM              PHONE NO : 901 867 9971   
5677 AIRLINE RD.                  SE DECISION MADE: 25-MAR-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAMPART O AND RAMPART P
SPINEOLOGY, INC.                  510(k) NO: K130396(SPECIAL)
ATTN: BRYAN  BECKER               PHONE NO : 612 256 8534   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 25-MAR-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
LAUER MEMBRAN WASSERTECHNIK GMBH  510(k) NO: K124059(TRADITIONAL)
ATTN: STEPHAN  KRIETEMEYER        PHONE NO : 49 7621 927015
9 SPEICHERMATT                    SE DECISION MADE: 25-MAR-13
WITTLINGEN    GM DE 79599         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
BIOMECANICA INDUSTRIA E COMERICO D510(k) NO: K123745(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 25-MAR-13
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIFELINES IEEG
KVIKNA EHF                        510(k) NO: K123665(TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 25-MAR-13
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K130754(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 650 969 9112   
685 EAST MIDDLEFIELD RD.          SE DECISION MADE: 25-MAR-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SMART-WELL INCUBATOR
MESA LABORATORIES, INC.           510(k) NO: K122362(SPECIAL)
ATTN: JOLE  WILSON                PHONE NO : 303 987 8000   
12100 W. 6TH AVENUE               SE DECISION MADE: 26-MAR-13
LAKEWOOD CO 80228                 510(k) STATEMENT
 
DEVICE: INSIGNIA DIGICAST
ORMCO CORP.                       510(k) NO: K123118(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 26-MAR-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NOBELCLINICIAN
NOBEL BIOCARE AB                  510(k) NO: K123976(TRADITIONAL)
ATTN: PHUONG  NGUYEN              PHONE NO : 714 282 4800   
22715 SAVI RANCH PARKWAY          SE DECISION MADE: 26-MAR-13
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
PAN-AMERICA HYPERBARICS, INC.     510(k) NO: K122560(TRADITIONAL)
ATTN: WILLIAM M GATES, RRT        PHONE NO : 913 674 3118   
1510 PARK PLACE DRIVE             SE DECISION MADE: 26-MAR-13
ATCHISON KS 66002                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HIGH METABOLITE QUALICHECK
RADIOMETER MEDICAL APS            510(k) NO: K130415(TRADITIONAL)
ATTN: MARTIN  GABLER              PHONE NO : 45 382731 14
AAKANDEVEJ 21                     SE DECISION MADE: 26-MAR-13
BROENSHOEJ    DA DK-2700          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRASAFE PLUS PASSIVE NEEDLE GUARD
SAFETY SYRINGES, INC.             510(k) NO: K123743(TRADITIONAL)
ATTN: SUZANNE  RICHARDSON         PHONE NO : 760 918 9908   
2875 LOKER AVENUE EAST            SE DECISION MADE: 26-MAR-13
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VENACURE EVLT NEVERTOUCH PROCEDURE KIT
ANGIODYNAMICS, INC.               510(k) NO: K130671(SPECIAL)
ATTN: TERI  JUCKETT               PHONE NO : 518 795 1142   
603 QUEENSBURY AVE.               SE DECISION MADE: 26-MAR-13
QUEENSBURY NY 12804               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TBD
LENSAR, INC.                      510(k) NO: K123859(TRADITIONAL)
ATTN: SHIRLEY K MCGARVEY          PHONE NO : 702 524 3701   
2800 DISCOVERY DRIVE SUITE 100    SE DECISION MADE: 27-MAR-13
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
THE BINDING SITE GROUP LTD        510(k) NO: K113823(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121456 9500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 27-MAR-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT
 
DEVICE: DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
MEDTRONIC INC.                    510(k) NO: K123762(TRADITIONAL)
ATTN: CHELSEA  PIOSKE             PHONE NO : 763 514 9838   
7611 NORTHLAND DR.                SE DECISION MADE: 27-MAR-13
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
INTERNATIONAL BIOPHYSICS CORPORATI510(k) NO: K122480(TRADITIONAL)
ATTN: H. DAVID  SHOCKLEY JR.      PHONE NO : 512 326 3244   
2101 E. ST ELMO ROAD SUITE 275    SE DECISION MADE: 27-MAR-13
AUSTIN TX 78744                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
HEMOSTASIS, LLC                   510(k) NO: K122494(TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 855 1466   
5000 Township Pkwy                SE DECISION MADE: 27-MAR-13
Saint Paul MN 55110               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
WESCOR, INC.                      510(k) NO: K121823(TRADITIONAL)
ATTN: DAWN T PERDUE               PHONE NO : 435 752 6011   
370 WEST 1700 SOUTH               SE DECISION MADE: 27-MAR-13
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MICROLINE FLEXIBLE LIGATING SHEARS
MICROLINE SURGICAL, INC           510(k) NO: K124029(TRADITIONAL)
ATTN: DEAN  CIPORKIN              PHONE NO : 978 867 1758   
800 CUMMING CENTER SUITE 166T     SE DECISION MADE: 27-MAR-13
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
MEGAGEN IMPLANT CO., LTD.         510(k) NO: K123870(SPECIAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE STREET UNIT B        SE DECISION MADE: 27-MAR-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
TECRES SPA                        510(k) NO: K122175(TRADITIONAL)
ATTN: CHRISTINE  BRAUER, PH.D.    PHONE NO : 301 545 1990   
7 TRAIL HOUSE COURT               SE DECISION MADE: 28-MAR-13
ROCKVILLE MD 20850                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTESS LUMBAR CAGE
KALITEC DIRECT, LLC               510(k) NO: K123100(TRADITIONAL)
ATTN: J D WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 28-MAR-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
BIOMET MANUFACTURING CORP.        510(k) NO: K122770(TRADITIONAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574 267 6639   
56 BELL DRIVE                     SE DECISION MADE: 28-MAR-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AGE AUTOMATIC WRIST BLOOD PRESSURE MONITOR
AGELESS HEALTH INDUSTRIAL         510(k) NO: K123645(TRADITIONAL)
ATTN: VICTOR  WAN                 PHONE NO : 07 698115 8038
NO.33 SHENBEI RD, SIMA VILLAGE CHASE DECISION MADE: 28-MAR-13
DONGGUAN CITY, GUANGDONG PROVINCE 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
MEDITECH ADVISORS, LLC            510(k) NO: K122850(TRADITIONAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264   
200 NOMER AVENUE                  SE DECISION MADE: 28-MAR-13
ASHLAND MA 01721                  510(k) STATEMENT
 
DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM
BLOCKADE MEDICAL                  510(k) NO: K123338(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
18 Technology Dr Ste 169          SE DECISION MADE: 28-MAR-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARDIOMEM
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K122272(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 28-MAR-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
MIMOSA ACOUSTICS, INC.            510(k) NO: K123624(SPECIAL)
ATTN: PATRICIA S JENG             PHONE NO : 217 359 9740   
335 N Fremont St                  SE DECISION MADE: 28-MAR-13
CHAMPAIGN IL 61820                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXSOS 3 TI LOCKING PLATE SYSTEM
STRYKER TRAUMA AG                 510(k) NO: K123964(TRADITIONAL)
ATTN: ESTELA  CELI                PHONE NO : 201 831 6461   
325 CORPORATE DRIVE               SE DECISION MADE: 28-MAR-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
PROSPERA CORPORATION              510(k) NO: K122744(TRADITIONAL)
ATTN: LEON E JEW                  PHONE NO : 925 463 3288   
5776 STONERIDGE MALL RD SUITE 288 SE DECISION MADE: 28-MAR-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
SUNMED LLC                        510(k) NO: K121743(TRADITIONAL)
ATTN: WU  TINGJIE                 PHONE NO : 86 757 28091300
5/F - 6/F, BLOCK A, GUPO GONGMAO BSE DECISION MADE: 28-MAR-13
DALIANG, SHUNDE, FOSHAN    CH 5283510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
ASI MEDICAL, INC.                 510(k) NO: K123139(TRADITIONAL)
ATTN: JOHN  MCPEEK                PHONE NO : 303 766 3646   
14550 E EASTER AVE. SUITE 700     SE DECISION MADE: 28-MAR-13
CENTENNIAL CO 80112               510(k) STATEMENT
 
DEVICE: STRYKER VENOM ELECTRODES AND CANNULAE
STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K123178(TRADITIONAL)
ATTN: CHRISTINA  MCKEE            PHONE NO : 269 389 4086   
4100 EAST MILHAM AVE.             SE DECISION MADE: 28-MAR-13
KALAMAZOO MI 49001                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FIREBIRD SPINAL FIXATION SYSTEM
ORTHOFIX                          510(k) NO: K130176(SPECIAL)
ATTN: JACKI  GEREN                PHONE NO : 214 937 2100   
3451 PLANO PARKWAY                SE DECISION MADE: 28-MAR-13
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM
BIODENTA SWISS AG                 510(k) NO: K123512(TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174711 11
TRAMSTRASSE 16                    SE DECISION MADE: 28-MAR-13
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUANTIEN MEASUREMENT SYSTEM
RADI MEDICAL SYSTEMS AB           510(k) NO: K123984(SPECIAL)
ATTN: ANNA-LISA  TIENSUU          PHONE NO : 46 18 161000
PALMBLADSGATAN 10                 SE DECISION MADE: 28-MAR-13
UPPSALA    SW S-754 50            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 12MM AND 13MM TIBIAL NAILS
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K130625(SPECIAL)
ATTN: ALLYSON  PARKS              PHONE NO : 310 533 9966   
386 Beech Ave. Unit B6            SE DECISION MADE: 28-MAR-13
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BOEHRINGER GASTRIC SIZING TUBE
BOEHRINGER LABORATORIES, LLC      510(k) NO: K130483(TRADITIONAL)
ATTN: CHRISTOPHER  RADL, ENGINEERIPHONE NO : 610 278 0900   
300 Thoms Drive                   SE DECISION MADE: 28-MAR-13
Phoenixville PA 19460             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
EIZO NANAO CORPORATION            510(k) NO: K130336(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627424 68
153 SHIMOKASHIWANO, HAKUSAN       SE DECISION MADE: 28-MAR-13
ISHIKAWA    JA 924-8566           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
NEOCOIL, LLC                      510(k) NO: K123272(ABBREVIATED)
ATTN: KATIE  GONZALEZ             PHONE NO : 262 347 1250   
N27 W23910A PAUL RD.              SE DECISION MADE: 28-MAR-13
PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
ST. SHINE OPTICAL CO., LTD.       510(k) NO: K123484(TRADITIONAL)
ATTN: ELLA  LEE                   PHONE NO : 886 226479 356
4,5 F/L NO. 276-2 SEC. 1 TATUNG RDSE DECISION MADE: 29-MAR-13
TAIPEI HSIEN    TW 221            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU
ETHICON ENDO-SURGERY, LLC         510(k) NO: K130653(SPECIAL)
ATTN: CAROL  HUBBARD              PHONE NO : 513 337 3792   
4545 CREEK ROAD                   SE DECISION MADE: 29-MAR-13
CINCINNATI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CELLULAZE LASER
CYNOSURE, INC.                    510(k) NO: K123407(TRADITIONAL)
ATTN: IRINA  KULINETS             PHONE NO : 978 367 2350   
5 CARLISLE ROAD                   SE DECISION MADE: 29-MAR-13
WESTFORD MA 01886                 510(k) STATEMENT
 
DEVICE: FLOWER SMALL AND MEDIUM BONE IMPLANTS
FLOWER ORTHOPEDICS CORPORATION    510(k) NO: K123562(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 29-MAR-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RMGI FILL
PULPDENT CORPORATION              510(k) NO: K130223(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617 926 6666   
80 OAKLAND ST.                    SE DECISION MADE: 29-MAR-13
WATERTOWN MA 02472                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K123509(TRADITIONAL)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 29-MAR-13
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
IVOCLAR VIVADENT, AGIN            510(k) NO: K124008(ABBREVIATED)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DRIVE                SE DECISION MADE: 29-MAR-13
AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION
LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K130497(SPECIAL)
ATTN: JONATHAN  WERNER            PHONE NO : 727 399 5574   
11311  Concept Boulevard          SE DECISION MADE: 29-MAR-13
LARGO FL 33773                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LITECURE THERAPY SYSTEM MODEL LTS-1500
LITECURE, LLC                     510(k) NO: K123014(TRADITIONAL)
ATTN: LIANG  LU                   PHONE NO : 302 709 0408   
250 Corporate Blvd. Suite B       SE DECISION MADE: 29-MAR-13
NEWARK DE 19702                   510(k) STATEMENT
 
DEVICE: MUSCLE STIMULATION SYSTEM
NIVEUS MEDICAL, INC.              510(k) NO: K123642(TRADITIONAL)
ATTN: CINDY  DOMECUS, R.A.C. (US &PHONE NO : 650 343 4813   
1171 BARROILHET DRIVE             SE DECISION MADE: 29-MAR-13
HILLSBOROUGH CA 94010             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
BIOPSY SCIENCES, LLC              510(k) NO: K130537(SPECIAL)
ATTN: SHARON  ROCKWELL            PHONE NO : 714 695 9269   
5582 CHALON RD.                   SE DECISION MADE: 29-MAR-13
YORBA LINDA CA 92886              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K122221(SPECIAL)
ATTN: MEIRU  LI                   PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 29-MAR-13
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AEI DR. TERAUCHI ULTRASONIC TIPS
AMERICAN EAGLE INSTRUMENTS, INC.  510(k) NO: K122501(TRADITIONAL)
ATTN: KRISTEN  SCHALLIOL          PHONE NO : 406 549 7451   
6575 BUTLER CREEK ROAD            SE DECISION MADE: 29-MAR-13
MISSOULA MT 59808                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SWIFT FX NANO
RESMED LTD.                       510(k) NO: K123789(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 29-MAR-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
 
                                                 TOTAL 510(k)s THIS PERIOD   283                                     
                                                 TOTAL WITH SUMMARIES        268                                     
                                                 TOTAL WITH STATEMENTS        15