March 2013 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period March 2013.
TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 12
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, RS-3000 LITE
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: 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: 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: 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: 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: 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: 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: 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: 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
