January 2013 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2013
DEVICE: LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
DIASORIN, INC. 510(k) NO: K121944(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651 439 9710
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 01-JAN-13
STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
GE HEALTHCARE 510(k) NO: K122457(TRADITIONAL)
ATTN: MALCA PHONE NO : 003 364 6373852
283, RUE DE LA MINIERE SE DECISION MADE: 02-JAN-13
BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K123877(SPECIAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367
100 DENNIS DR. SE DECISION MADE: 02-JAN-13
Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERVENTIONAL WORKSPOT
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121296(TRADITIONAL)
ATTN: FRANS JACOBS PHONE NO : 314 027 99709
VEENPLUIS 4-6 SE DECISION MADE: 02-JAN-13
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
MENICON CO. LTD. 510(k) NO: K122273(ABBREVIATED)
ATTN: ELLEN M BEUCLER PHONE NO : 978 658 6888
187 BALLARDVALE STREET SUITE 180 SE DECISION MADE: 02-JAN-13
WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM
STRYKER 510(k) NO: K123452(SPECIAL)
ATTN: JEAN CHEN PHONE NO : 510 413 2591
47900 BAYSIDE PARKWAY SE DECISION MADE: 03-JAN-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLADENTAL BARRIER
COLLAMATRIX, INC 510(k) NO: K100695(TRADITIONAL)
ATTN: DENNIS J. N. SEAH PHONE NO : 886 277 113299
26F, NO. 105, SECTION 2 DUNHUA SOUSE DECISION MADE: 03-JAN-13
TAIPEI TW 106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER STAPLE(TM) CLASSIC
METRIC MEDICAL DEVICES, INC. 510(k) NO: K123363(TRADITIONAL)
ATTN: W CASEY FOX PHD PE PHONE NO : 830 535 6300
846 SILVER SPRINGS SE DECISION MADE: 03-JAN-13
HELOTES TX 78023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOVEREIGN MINI
AESCULAP, INC. 510(k) NO: K123102(SPECIAL)
ATTN: DENISE ADAMS PHONE NO : 610 984 9076
3773 CORPORATE PARKWAY SE DECISION MADE: 03-JAN-13
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPHOTAS LIFELIGHT
BIOPHOTAS, INC. 510(k) NO: K122237(TRADITIONAL)
ATTN: SHEPARD G BENTLEY, RAC PHONE NO : 949 495 4274
28241 CROWN VALLEY PARKWAY, SUITE SE DECISION MADE: 03-JAN-13
LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOPPLEX ABILITY
HUNTLEIGH HEALTHCARE 510(k) NO: K121108(TRADITIONAL)
ATTN: DAVID MOYNHAM PHONE NO : 442 920 485885
35 PORTMANMOOR ROAD SE DECISION MADE: 03-JAN-13
CARDIFF UK CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETRACTA DETACHABLE EMBOLIZATION COIL
COOK INCORPORATED 510(k) NO: K123712(SPECIAL)
ATTN: JENNIFER RICHARDSON PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 03-JAN-13
BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO ERCP GUIDEWIRE
NEOMETRICS, INC. 510(k) NO: K123439(TRADITIONAL)
ATTN: GENE CHAMPEAU PHONE NO : 763 559 4440
2605 FERNBROOK LANE N. SUITE J SE DECISION MADE: 03-JAN-13
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
MOOR INSTRUMENTS LTD. 510(k) NO: K122943(TRADITIONAL)
ATTN: STEWART LILLINGTON PHONE NO : 441 297357 15
MILLWEY SE DECISION MADE: 03-JAN-13
AXMINSTER, DEVON UK EX135HU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
NORTH AMERICAN RESCUE PRODUCTS, IN510(k) NO: K123194(TRADITIONAL)
ATTN: WILLIAM SLEVIN PHONE NO : 864 675 9800
35 TEDWALL COURT SE DECISION MADE: 03-JAN-13
GREER SC 29650 4791 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEARL DIABETES MANAGEMENT SYSTEM
ASANTE SOLUTIONS, INC. 510(k) NO: K122483(SPECIAL)
ATTN: ROBIN BUSH PHONE NO : 408 716 5600
352 E Java Dr SE DECISION MADE: 03-JAN-13
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG+ ARROW PICC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K123759(SPECIAL)
ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131
2400 Bernville Road SE DECISION MADE: 03-JAN-13
Reading PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K121975(TRADITIONAL)
ATTN: BRETT WHISTON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 03-JAN-13
ACKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
DEFIBTECH, LLC 510(k) NO: K113787(TRADITIONAL)
ATTN: ED HORTON PHONE NO : 203 453 6654
741 BOSTON POST ROAD,SUITE 201 SE DECISION MADE: 04-JAN-13
GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY FAT SCALE MODEL SF-371
SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K122976(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931 625 4938
77325 JOYCE WAY SE DECISION MADE: 04-JAN-13
ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
OLYMPUS KEYMED (MEDICAL & INDUSTRI510(k) NO: K122818(TRADITIONAL)
ATTN: RONALD S WARREN PHONE NO : 858 753 1961
11440 WEST BERNARDO DRIVE SUITE 30SE DECISION MADE: 04-JAN-13
SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K122854(TRADITIONAL)
ATTN: JULIE LAWSON PHONE NO : 610 378 0131
2400 BERNVILLE RD. SE DECISION MADE: 04-JAN-13
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERASOM-CAST
FAMILY DENTAL SERVICES, P.C. 510(k) NO: K113516(TRADITIONAL)
ATTN: DEANNA L BAXAM PHONE NO : 678 896 1986
2180 SATELLITE BOULEVARD SUITE 400SE DECISION MADE: 04-JAN-13
DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTINCT JAVA SYSTEM
ZIMMER SPINE 510(k) NO: K122592(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952 830 6205
7375 BUSH LAKE ROAD SE DECISION MADE: 04-JAN-13
EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K123731(SPECIAL)
ATTN: PAUL KRUMM PHONE NO : 973 889 7339
1500 LITTLETON ROAD SE DECISION MADE: 04-JAN-13
PARSIPPANY NJ 07054 510(k) STATEMENT
DEVICE: K7C SPACER
K7 LLC 510(k) NO: K123388(TRADITIONAL)
ATTN: KARREN E WARDEN, PHD PHONE NO : 440 729 8457
PO BOX 566 SE DECISION MADE: 04-JAN-13
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE MODEL V5000, V5100, V5000C, V5100C
MIDMARK CORP. 510(k) NO: K122643(TRADITIONAL)
ATTN: MARK GREENWOOD PHONE NO : 847 415 9800
675 HEATHROW DRIVE SE DECISION MADE: 07-JAN-13
LINCOLNSHIRE IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TS IMPLANT SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K121585(TRADITIONAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001
85 BEN FAIRLESS DR. SE DECISION MADE: 07-JAN-13
FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINSWAY DEEP TMS SYSTEM
BRAINSWAY, LTD 510(k) NO: K122288(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976700 02
20 HATA’AS ST. (POB 124) SE DECISION MADE: 07-JAN-13
KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIE TOTAL HB TEST SYSTEM
MEC DYNAMICS CORP 510(k) NO: K121752(TRADITIONAL)
ATTN: EMMANUAL MPOCK PHONE NO : 408 428 9721
90 ROSE ORCHARD WAY SE DECISION MADE: 07-JAN-13
SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTEROCOCCUS QUICKFISH BC
ADVANDX, INC. 510(k) NO: K121991(TRADITIONAL)
ATTN: BENJAMIN S CRYSTAL PHONE NO : 781 376 0009
400 TRADECENTER SUITE 6990 SE DECISION MADE: 07-JAN-13
WOBURN MA 01801 510(k) STATEMENT
DEVICE: MEGA 5.5 SPINE SYSTEM
LSK BIOPARTNERS, INC. 510(k) NO: K123476(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 714 313 7442
8 EAST BROADWAY, STE 611 SE DECISION MADE: 08-JAN-13
SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN TENDON SHEET-D
ROTATION MEDICAL, INC. 510(k) NO: K122048(TRADITIONAL)
ATTN: JEFF SIMS PHONE NO : 763 746 7502
15350 25TH AVENUE N SUITE 100 SE DECISION MADE: 08-JAN-13
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
BAXTER HEALTHCARE CORP. 510(k) NO: K123868(SPECIAL)
ATTN: GARY CHUMBIMUNE PHONE NO : 224 270 3312
32650 N WILSON RD. SE DECISION MADE: 08-JAN-13
ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FALCON SPACER
SYNTHES (USA) PRODUCTS LLC 510(k) NO: K123180(TRADITIONAL)
ATTN: MONIKA MCDOLE-RUSSELL PHONE NO : 610 719 5424
1302 WRIGHTS LANE EAST SE DECISION MADE: 08-JAN-13
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP MUITISCOPE
ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K121261(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 061 15626
AMSTEL 320-I SE DECISION MADE: 08-JAN-13
AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLEABLE TIP ENDOSCOPIC APPLICATOR
MICROMEDICS, INC. 510(k) NO: K123847(SPECIAL)
ATTN: JODI L RAUS PHONE NO : 651 452 1977
1270 EAGAN INDUSTRIAL ROAD SUITE 1SE DECISION MADE: 08-JAN-13
Saint Paul MN 55121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIGNRT PLUS
VISION RT LIMITED 510(k) NO: K123371(TRADITIONAL)
ATTN: NORMAN SMITH PHONE NO : 44 020 83464300
Dove House Arcadia Avenue SE DECISION MADE: 08-JAN-13
LONDON GB N3 2JU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLOCEM
COLTENE/WHALEDENT AG 510(k) NO: K121621(TRADITIONAL)
ATTN: SILKE WALLASCHEK PHONE NO : 410 717575 852
FELDWIESENSTRASSE 20 SE DECISION MADE: 08-JAN-13
ALTSTATTEN SZ CH-9450 510(k) STATEMENT
DEVICE: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
TORNIER SAS 510(k) NO: K122698(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 781 249 8030
10801 NESBITT AVENUE SOUTH SE DECISION MADE: 08-JAN-13
BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
ELEVEN BLADE SOLUTIONS, INC. 510(k) NO: K122336(TRADITIONAL)
ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626
14734 LA RINCONADA DRIVE SE DECISION MADE: 09-JAN-13
LOS GATOS CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
LUMINEX CORP. 510(k) NO: K121399(TRADITIONAL)
ATTN: OLIVER MEEK PHONE NO : 512 219 8020
12212 Technology Blvd SE DECISION MADE: 09-JAN-13
AUSTIN TX 78727 510(k) STATEMENT
DEVICE: AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
MEDTRONIC INC. 510(k) NO: K122914(TRADITIONAL)
ATTN: JULIA A NELSON PHONE NO : 763 514 9844
7611 NORTHLAND DRIVE SE DECISION MADE: 09-JAN-13
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
BIO-RAD LABORATORIES 510(k) NO: K123798(TRADITIONAL)
ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467
9500 JERONIMO RD. SE DECISION MADE: 09-JAN-13
IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEST LOCALIZATION NEEDLE WITH I-125 SEED
BEST MEDICAL INTL. 510(k) NO: K122704(TRADITIONAL)
ATTN: DHARMENDRA THAKUR PHONE NO : 703 451 2378
7643 FULLERTON ROAD SE DECISION MADE: 09-JAN-13
SPRINGFIELD VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER CROSSFLOW ARTHROSCOPY PUMP
STRYKER ENDOSCOPY 510(k) NO: K123441(TRADITIONAL)
ATTN: KEVIN POTGIETER PHONE NO : 408 754 2000
5900 OPTICAL CT. SE DECISION MADE: 09-JAN-13
SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
BECTON DICKINSON & CO. 510(k) NO: K123213(TRADITIONAL)
ATTN: JOHN ROBERTS PHONE NO : 201 847 5473
1 BECTON DR. MC237 SE DECISION MADE: 09-JAN-13
FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTIMA TRICHOMONAS VAGINALIS ASSAY – PANTHER
GEN-PROBE, INC. 510(k) NO: K122062(TRADITIONAL)
ATTN: MARIA CARMELITA S BALUYOT PHONE NO : 858 410 8309
10210 GENETIC CENTER DR. SE DECISION MADE: 09-JAN-13
SAN DIEGO CA 92121 4362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERITS MODEL P322FWD POWERED WHEELCHAIR
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K122357(ABBREVIATED)
ATTN: STEVE CHAO PHONE NO : 886 4 2359X200
NO.18 JINGKE RD. NANTUN DIST SE DECISION MADE: 09-JAN-13
TAICHUNG TW 40852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSTEK GLASS BODY FAT ANALYZER
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K123781(SPECIAL)
ATTN: LEO WANG PHONE NO : 086 28 86083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 09-JAN-13
CHENGDU, SICHUAN CH 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
UCP BIOSCIENCES, INC. 510(k) NO: K123863(SPECIAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 09-JAN-13
SAN JOSE CA 95112 510(k) STATEMENT
DEVICE: SENOMARK ULTRA BREAST TISSUE MARKER
C.R. BARD, INC. 510(k) NO: K123911(SPECIAL)
ATTN: SARAH MCCARTNEY PHONE NO : 480 638 2954
1625 WEST 3RD ST. SE DECISION MADE: 10-JAN-13
TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EC SINGLE USE, POLYPECTOMY SNARE
ENDOCHOICE, INC. 510(k) NO: K123223(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092
1914 J.N. PEASE PLACE SE DECISION MADE: 10-JAN-13
CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD CULTURE HOLDER
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K122687(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410 592 2060
P.O. BOX 103 SE DECISION MADE: 10-JAN-13
BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
SPINAL ELEMENTS, INC. 510(k) NO: K122771(TRADITIONAL)
ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 10-JAN-13
CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
MEDTRONIC ADVANCED ENERGY, LLC 510(k) NO: K123201(TRADITIONAL)
ATTN: JANET KWIATKOWSKI PHONE NO : 603 842 6283
180 INTERNATIONAL DRIVE SE DECISION MADE: 10-JAN-13
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW COMFORT-FIT DENTAL GUARD
DENTEK ORAL CARE, INC. 510(k) NO: K123849(SPECIAL)
ATTN: LINDA GILES PHONE NO : 865 983 1300
307 EXCELLENCE WAY SE DECISION MADE: 10-JAN-13
MARYVILLE TN 37801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
BAXTER HEALTHCARE CORP. 510(k) NO: K123874(SPECIAL)
ATTN: NANETTE HEDDEN PHONE NO : 224 270 4871
32650 N WILSON RD. SE DECISION MADE: 10-JAN-13
ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.FLEX BY TCS
THERMOPLASTIC COMFORT SYSTEMS, INC510(k) NO: K123396(TRADITIONAL)
ATTN: MARLIN POSCA PHONE NO : 526 426 2970
2619 LIME AVENUE SE DECISION MADE: 10-JAN-13
SIGNAL HILL CA 90755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENX STONE MANAGEMENT DEVICE
XENOLITH MEDICAL 510(k) NO: K123438(SPECIAL)
ATTN: OFER ZIGMAN PHONE NO : 972 8 6811761
Leshem 1 SE DECISION MADE: 10-JAN-13
Kiryat Gat IL 82000 510(k) STATEMENT
DEVICE: OPTETRAK LOGIC CRC TIBIAL INSERT
EXACTECH, INC. 510(k) NO: K123342(SPECIAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 10-JAN-13
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-BEAM ND: YAG LASER
ECLIPSE AESTHETICS, LLC 510(k) NO: K122922(TRADITIONAL)
ATTN: TOM OBRIEN PHONE NO : 972 380 2911
13998 DIPLOMAT DRIVE SE DECISION MADE: 10-JAN-13
DALLAS TX 75234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-TOUCH IV
MYOSCIENCE INC 510(k) NO: K123516(TRADITIONAL)
ATTN: TRACEY HENRY PHONE NO : 650 474 2600
1600 SEAPORT BLVD, STE 450 NORTH LSE DECISION MADE: 10-JAN-13
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DETECT
FORUM ENGINEERING TECHNOLOGIES LTD510(k) NO: K121206(TRADITIONAL)
ATTN: YULIYA YUKEVICH PHONE NO : 972 396255 17
1 PLATIN ST, NEW INDUSTRIAL ZONE SE DECISION MADE: 10-JAN-13
RISHON LEZION IS 75653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA III VIDEO SYSTEM
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K121959(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484 896 5688
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 10-JAN-13
CENTER VALLY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ME
SYNERON BEAUTY LTD. 510(k) NO: K123845(SPECIAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET ST., 29TH FLOOR SE DECISION MADE: 10-JAN-13
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM3 AEM MONITOR AEM CONNECTORS
ENCISION, INC. 510(k) NO: K122383(TRADITIONAL)
ATTN: JIM LEWIS PHONE NO : 303 444 2600
6797 WINCHESTER CIR. SE DECISION MADE: 10-JAN-13
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC XOMED, INC.
MEDTRONIC XOMED, INC. 510(k) NO: K122391(TRADITIONAL)
ATTN: DOUGLAS JOHNSON PHONE NO : 904 286 9600
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 10-JAN-13
JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANOMETER
INTERSURGICAL, INC. 510(k) NO: K122077(TRADITIONAL)
ATTN: MICHAEL ZALEWSKI PHONE NO : 315 451 2900
417 ELECTRONICS PKWY. SE DECISION MADE: 10-JAN-13
LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
STANMORE IMPLANTS WORLDWIDE LTD 510(k) NO: K121765(TRADITIONAL)
ATTN: HOLLACE SAAS RHODES PHONE NO : 202 552 5807
1331 H STREET, NW, 12 FLOOR SE DECISION MADE: 11-JAN-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRASCANNER
INFRASCAN, INC. 510(k) NO: K120949(TRADITIONAL)
ATTN: STEVEN B DATLOF, M.D., J.D. PHONE NO : 267 675 4613
1835 MARKET ST., 29TH FLOOR SE DECISION MADE: 11-JAN-13
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K123048(TRADITIONAL)
ATTN: JORGE MILLAN PHONE NO : 305 925 1260
601 WEST 20TH STREET SE DECISION MADE: 11-JAN-13
HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECBOARD JR.
MACBRUD CORP., MEDICAL DIVISION 510(k) NO: K123414(TRADITIONAL)
ATTN: TODD LARY PHONE NO : 305 378 1958
14021 SW 143 COURT, UNIT 6 SE DECISION MADE: 11-JAN-13
MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IB CLINIC
IMAGING BIOMETRICS, LLC 510(k) NO: K123302(TRADITIONAL)
ATTN: MIKE SCHMAINDA PHONE NO : 262 439 8252
13416 Watertown Plank Rd Suite 260SE DECISION MADE: 11-JAN-13
Elm Grove WI 53122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
LORAD, A HOLOGIC CO. 510(k) NO: K122836(SPECIAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203 731 8337
36 APPLE RIDGE RD. SE DECISION MADE: 11-JAN-13
DANBURY CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTF NEW BONE VOID FILLER
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K121313(TRADITIONAL)
ATTN: NANCY JOY PHONE NO : 732 661 2381
125 MAY STREET SE DECISION MADE: 11-JAN-13
EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIZION + DR
VIZTEK LLC 510(k) NO: K123644(SPECIAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 11-JAN-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
CAMBER SPINE TECHNOLOGIES 510(k) NO: K121254(TRADITIONAL)
ATTN: DAN PONTECORVO PHONE NO : 484 420 4671
401 YANKEE COURT SE DECISION MADE: 11-JAN-13
NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
NINGBO DIAIER ELECTRONIC CO., LTD.510(k) NO: K123839(SPECIAL)
ATTN: LAO XIKUN PHONE NO : 86 0574 62463008
YAOXI INDUSTRIAL ZONE SE DECISION MADE: 11-JAN-13
YUYAO CITY, ZHEJIANG CH 315400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICAM FUNDUS CAMERA
OPTOVUE, INC. 510(k) NO: K122572(TRADITIONAL)
ATTN: AZIMUN JAMAL PHONE NO : 510 623 8868
2800 Bayview Dr SE DECISION MADE: 11-JAN-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
STRYKER NEUROVASCULAR 510(k) NO: K122576(TRADITIONAL)
ATTN: JAMES LEATHLEY PHONE NO : 510 413 2500
47900 BAYSIDE PARKWAY SE DECISION MADE: 11-JAN-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER
ANGIOSCORE, INC. 510(k) NO: K122685(TRADITIONAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989
5055 BRANDIN COURT SE DECISION MADE: 11-JAN-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD-IVUS ULTRASOUND IMAGING SYSTEM
SILICON VALLY MEDICAL INSTRUMENTS,510(k) NO: K122878(SPECIAL)
ATTN: RICHARD E ANDERSON PHONE NO : 510 897 4695
47697 WESTINGHOUSE SUITE 101 SE DECISION MADE: 11-JAN-13
FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVIX-S WITH VXVUE
VIEWORKS CO., LTD. 510(k) NO: K122866(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080
951 STARBUCK ST UNIT J SE DECISION MADE: 11-JAN-13
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTRA 7F CATHETERS
BIOTRONIK, INC. 510(k) NO: K123324(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374
6024 JEAN ROAD SE DECISION MADE: 11-JAN-13
LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T GEM RT OPEN ARRAY
GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K123327(TRADITIONAL)
ATTN: ANDREW MENDEN PHONE NO : 262 521 6223
1515 DANNER DR SE DECISION MADE: 11-JAN-13
AURORA OH 44202 9273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWEREASE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123270(TRADITIONAL)
ATTN: JULIE BASSETT PHONE NO : 800 876 3133
1800 PYRAMID PLACE SE DECISION MADE: 11-JAN-13
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QXMEDICAL ACCESS & SUPPORT CATHETER
QXMEDICAL, LLC 510(k) NO: K123311(TRADITIONAL)
ATTN: FERNANDO DI CAPRIO PHONE NO : 651 338 5774
1843 Buerkle Rd SE DECISION MADE: 14-JAN-13
White Bear Lake MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K123905(SPECIAL)
ATTN: HYE-JOO KIM, PHARM. D PHONE NO : 404 639 4643
1600 CLIFTON RD. NE (MS C-18) SE DECISION MADE: 14-JAN-13
ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
ABBOTT LABORATORIES 510(k) NO: K123372(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972 518 6711
1921 HURD DR. SE DECISION MADE: 14-JAN-13
IRVING TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMESENSE FOR SENSITIVE TEETH
SYLPHAR N.V. 510(k) NO: K122708(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 390 657 82665
PIAZZA ALBANIA 10 SE DECISION MADE: 14-JAN-13
ROME, ITALY IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC. 510(k) NO: K122870(TRADITIONAL)
ATTN: AMITA S SHAH PHONE NO : 781 345 9164
11 NORTH AVENUE SE DECISION MADE: 14-JAN-13
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF TL AND PL CAGE
COALIGN INNOVATIONS, INC. 510(k) NO: K123752(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 14-JAN-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
FORA CARE INC. 510(k) NO: K121706(TRADITIONAL)
ATTN: PINJUNG CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 14-JAN-13
NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
VOLCANO CORPORATION 510(k) NO: K123898(SPECIAL)
ATTN: JWALA JAWHARKAR PHONE NO : 916 281 2925
2870 KILGORE RD. SE DECISION MADE: 14-JAN-13
RANCHO CORDOVA CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K123878(SPECIAL)
ATTN: SHANNON SCOTT PHONE NO : 210 515 4368
6203 FARINON DRIVE SE DECISION MADE: 15-JAN-13
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRA LASERS
MIRA LASERS LLC 510(k) NO: K123004(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122815 850
P.O. BOX 237-023 SE DECISION MADE: 15-JAN-13
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILAB ULTRASOUND IMAGING SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K123535(SPECIAL)
ATTN: LORI R SMITH PHONE NO : 510 624 1698
47215 LAKEVIEW SE DECISION MADE: 15-JAN-13
FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS
CAREMED SUPPLY, INC. 510(k) NO: K122873(SPECIAL)
ATTN: MICHAEL LEE PHONE NO : 886 2 28096995
7F, NO.2, LANE 235, BAO CHIAO RD NSE DECISION MADE: 15-JAN-13
TAIPEI XEN DISTRICT CH 23145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K123788(TRADITIONAL)
ATTN: PETER J CORONADO PHONE NO : 650 424 6320
3100 HANSEN WAY SE DECISION MADE: 15-JAN-13
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGO IMAGING SYSTEM
DIGIRAD CORP. 510(k) NO: K123408(TRADITIONAL)
ATTN: MATTHEW OLOW PHONE NO : 858 726 1309
13950 STOWE DRIVE SE DECISION MADE: 15-JAN-13
POWAY CA 92064 8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCS-B
NIBEC COMPANY, LIMITED 510(k) NO: K113246(TRADITIONAL)
ATTN: DANIEL NAM PHONE NO : 213 626 1544
4568 W. 1ST STREET SUITE 104 SE DECISION MADE: 16-JAN-13
LOS ANGELES CA 90004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO DYNAMICS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123922(TRADITIONAL)
ATTN: YURI IKEDA PHONE NO : 734 205 2442
400 W. MORGAN ROAD SUITE 100 SE DECISION MADE: 16-JAN-13
ANN ARBOR MI 48108 9117 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRO HMPV+ ASSAY
GEN-PROBE PRODESSE, INC. 510(k) NO: K123838(SPECIAL)
ATTN: KAREN HARRINGTON PHONE NO : 262 953 8415
20925 CROSSROADS CIRCLE SE DECISION MADE: 16-JAN-13
Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
EXACTECH, INC. 510(k) NO: K121392(SPECIAL)
ATTN: LINDY KNISELY PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-JAN-13
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
SANITAS, INC. 510(k) NO: K123671(TRADITIONAL)
ATTN: ALAN DONALD PHONE NO : 858 485 8584
11440 W. BERNARDO COURT, STE 300 SE DECISION MADE: 16-JAN-13
SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DK-PTCA BALLOON CATHETER
INTUIT MEDICAL, LLC 510(k) NO: K123264(TRADITIONAL)
ATTN: JACK C GRIFFIS PHONE NO : 404 583 6889
6018 EAGLE’S REST TRAIL SE DECISION MADE: 16-JAN-13
SUGAR HILL GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURIGA QI
STARMEDTEC GMBH 510(k) NO: K121570(TRADITIONAL)
ATTN: GREGOR WEIDEMANN PHONE NO : 498 151 268610
KREUZSTRASSE 22 SE DECISION MADE: 16-JAN-13
STARNBERG GM 82319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT HYDROPHILIC GUIDE WIRE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K123609(SPECIAL)
ATTN: STEPHANIE ERSKINE PHONE NO : 801 208 4349
1111 South Velasco St SE DECISION MADE: 16-JAN-13
Angleton TX 77515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWISS LITHOBREAKER
EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K123038(TRADITIONAL)
ATTN: SUZANNE GOODMAN PHONE NO : 919 608 6082
225 TURNPIKE ROAD SE DECISION MADE: 16-JAN-13
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGASTRO SSCS ASSAY
GEN-PROBE PRODESSE, INC. 510(k) NO: K123274(TRADITIONAL)
ATTN: KAREN HARRINGTON PHONE NO : 262 953 8415
20925 CROSSROADS CIRCLE SE DECISION MADE: 16-JAN-13
Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
CONVENTUS ORTHOPAEDICS 510(k) NO: K102689(TRADITIONAL)
ATTN: HOLLACE S RHODES PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 17-JAN-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIVO MR355, OPTIMA MR360
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K123417(TRADITIONAL)
ATTN: RUOQIAN LIU PHONE NO : 86 10 58068943
NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 17-JAN-13
BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
CYPRESS MEDICAL PRODUCTS LLC 510(k) NO: K122788(TRADITIONAL)
ATTN: ANTONIO GIACCIO PHONE NO : 815 385 0100
1202 SOUTH ROUTE 31 SE DECISION MADE: 17-JAN-13
MCHENRY IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
MOLNLYCKE HEALTH CARE 510(k) NO: K122132(TRADITIONAL)
ATTN: ANGELA L BUNN PHONE NO : 678 250 7930
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 17-JAN-13
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEPHYR ‘X-SERIES” PATIENT TRANSFER SLED
DIACOR, INC. 510(k) NO: K121929(TRADITIONAL)
ATTN: KEVIN ANDERSON PHONE NO : 801 467 0050
2550 DECKER LAKE BLVD. SUITE 26 SE DECISION MADE: 17-JAN-13
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE
MED-FIBERS, INC. 510(k) NO: K124003(TRADITIONAL)
ATTN: ARMIN KAUS PHD PHONE NO : 480 516 8454
2675 E. BARTLETT PLACE SE DECISION MADE: 17-JAN-13
CHANDLER AZ 85249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
ICAD, INC. 510(k) NO: K122951(TRADITIONAL)
ATTN: JOHN A DELUCIA PHONE NO : 603 882 5200
98 SPIT BROOK ROAD SUITE 100 SE DECISION MADE: 17-JAN-13
NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRUX VENA CAVA FILTER SYSTEM
CRUX BIOMEDICAL 510(k) NO: K122585(SPECIAL)
ATTN: ELISA HEBB PHONE NO : 650 321 9903
1455 ADAMS DRIVE, #1170 SE DECISION MADE: 17-JAN-13
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERO I DENTAL IMPLANT SYSTEM
KJ MEDITECH CO., LTD 510(k) NO: K121098(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080
951 STARBUCK ST. UNIT J SE DECISION MADE: 17-JAN-13
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
SURGICAL INNOVATIONS PLC 510(k) NO: K123110(SPECIAL)
ATTN: TRACEY FEARNLEY PHONE NO : 440 11 32307597
CLAYTON WOOD HOUSE, 6 CLAYTON WOODSE DECISION MADE: 17-JAN-13
LEEDS, WEST YORKSHIRE UK LS16 6510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K121421(SPECIAL)
ATTN: COLLEEN DURRAN PHONE NO : 781 699 4480
920 WINTER STREET SE DECISION MADE: 17-JAN-13
WALTHAM MA 01854 1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K123734(TRADITIONAL)
ATTN: KIMBERLY GEISLER PHONE NO : 801 565 2422
9450 S State St SE DECISION MADE: 17-JAN-13
SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORB-X G
KLS-MARTIN L.P. 510(k) NO: K121606(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904 641 7746
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 17-JAN-13
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K123612(TRADITIONAL)
ATTN: KENT PRUETT PHONE NO : 830 372 1391
940 CROSSROADS BLVD. SE DECISION MADE: 17-JAN-13
SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
CINCINNATI SUB-ZERO PRODUCTS, INC 510(k) NO: K123946(SPECIAL)
ATTN: STEVEN J BERKE PHONE NO : 513 772 8810
12011 MOSTELLER ROAD SE DECISION MADE: 17-JAN-13
CINCINNATI OH 45241 1528 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
HONGYE PLASTIC PRODUCTS CO., LTD. 510(k) NO: K122408(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611
3973 SCHAFER AVE. SE DECISION MADE: 17-JAN-13
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
ST. JUDE MEDICAL NEUROMODULATION 510(k) NO: K123299(TRADITIONAL)
ATTN: TERRINA WILDER, RAC PHONE NO : 972 309 8115
6901 PRESTON RD. SE DECISION MADE: 18-JAN-13
PLANO TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNESIS PEEK CAGE
BK MEDITECH CO., LTD. 510(k) NO: K120464(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 714 313 7442
8 EAST BROADWAY, STE 611 SE DECISION MADE: 18-JAN-13
SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.VIA
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K123920(TRADITIONAL)
ATTN: SABINE SCHROEDEL PHONE NO : 499 131848 285
HENKESTRASSE 127 SE DECISION MADE: 18-JAN-13
ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BD PEN NEEDLE
BECTON DICKINSON & CO. 510(k) NO: K123300(SPECIAL)
ATTN: PASQUALE AMATO PHONE NO : 201 847 4513
1 BECTON DR. MC 372 SE DECISION MADE: 18-JAN-13
FRANKLIN LAKES NJ 07417 1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
VASONOVA INC. 510(k) NO: K123813(SPECIAL)
ATTN: CHRISTINE FORD PHONE NO : 610 378 0131
155 JEFFERSON DRIVE SUITE 100 SE DECISION MADE: 18-JAN-13
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K122768(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202 637 3638
555 THIRTEENTH STREET, NW SE DECISION MADE: 18-JAN-13
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIAC VX
GE MEDICAL SYSTEMS, LLC 510(k) NO: K121762(TRADITIONAL)
ATTN: MICHELLE HUETTNER PHONE NO : 262 521 6102
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 18-JAN-13
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
TEKMEDIC (M) SDN BHD 510(k) NO: K121592(TRADITIONAL)
ATTN: PATRICK LEONG PHONE NO : 606 351095 9
PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 18-JAN-13
JETTY, TANJUNG KLING, MALACCA M510(k) STATEMENT
DEVICE: CALIBER SPACERS
GLOBUS MEDICAL INC. 510(k) NO: K123231(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 18-JAN-13
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPACE BURR HOLE COVER MODEL 8110
NEUROPACE INC 510(k) NO: K123163(TRADITIONAL)
ATTN: ISABELLA ABATI PHONE NO : 650 237 2777
455 N. BERNARDO AVE SE DECISION MADE: 18-JAN-13
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVUE WITH NORMATIVE DATABASE
OPTOVUE, INC. 510(k) NO: K121739(TRADITIONAL)
ATTN: AZIMUN JAMAL PHONE NO : 510 623 8868
45531 Northport Loop W SE DECISION MADE: 18-JAN-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINUS FOSSA SPECIFIC PLATE SYSTEM
SKELETAL DYNAMICS, LLC 510(k) NO: K122310(TRADITIONAL)
ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585
8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 18-JAN-13
MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XGEO GC80
SAMSUNG ELECTRONICS CO., LTD. 510(k) NO: K123098(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 541 376 5063
77325 JOYCE WAY SE DECISION MADE: 18-JAN-13
ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
NITRILIST GLOVES MANUFACTURING SDN510(k) NO: K123328(TRADITIONAL)
ATTN: LAU SIONG HUT PHONE NO : 606 481 1876
PT 197, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 18-JAN-13
KUALA PILAH MY 72000 510(k) STATEMENT
DEVICE: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
HITACHI ALOKA MEDICAL, LTD. 510(k) NO: K123828(TRADITIONAL)
ATTN: ANGELA VAN ARSDALE PHONE NO : 203 269 5088
10 FAIRFIELD BLVD. SE DECISION MADE: 18-JAN-13
WALLINGFORD CT 06492 5903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
MEDTRONIC INC. 510(k) NO: K123314(TRADITIONAL)
ATTN: MARY E DONLIN PHONE NO : 763 526 9172
7611 NORTHLAND DRIVE SE DECISION MADE: 22-JAN-13
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TBA
MIGADA PLANT 510(k) NO: K121269(TRADITIONAL)
ATTN: YOSSI SHACHAR PHONE NO : 972 469 08800
NORTH INDUSTRIAL ZONE SE DECISION MADE: 22-JAN-13
KIRYAT SHMONA IS 10258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTENSE PULSED LIGHT (IPL) SYSTEMS
BEIJING KES BIOLOGY TECHNOLOGY CO.510(k) NO: K122995(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122815 850
P.O. BOX 237-023 SE DECISION MADE: 22-JAN-13
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATHETER CONNECTIONS’ DARK BLUE DUALCAP FOR MALE LUERS
CATHETER CONNECTIONS, INC. 510(k) NO: K123967(SPECIAL)
ATTN: DONALD D SOLOMON PHONE NO : 801 209 1269
615 Arapeen Dr Ste 302A SE DECISION MADE: 22-JAN-13
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMASORB DISPOSABLE FIXATION DEVICE
C.R. BARD INC 510(k) NO: K123718(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 401 825 8464
100 CROSSINGS BOULEVARD SE DECISION MADE: 22-JAN-13
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAPSE 3D COLON ANALYSIS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K123566(TRADITIONAL)
ATTN: JYH-SHYAN LIN PHONE NO : 301 301 1092
419 WEST AVE. SE DECISION MADE: 22-JAN-13
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.VIA MI WORKFLOWS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123577(SPECIAL)
ATTN: ALAINE MEDIO, RAC PHONE NO : 865 218 2703
810 INNOVATION DR. SE DECISION MADE: 22-JAN-13
KNOXVILLE TN 37934 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT FA PLUS CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K121461(TRADITIONAL)
ATTN: JOCELYN JENNINGS PHONE NO : 919 620 2894
100 RODOLPHE ST SE DECISION MADE: 22-JAN-13
DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPAIRX VENTILATING AIR PURIFIER
AIR INNOVATIONS, INC. 510(k) NO: K112728(TRADITIONAL)
ATTN: LAWRENCE WETZEL PHONE NO : 315 452 7400
7000 PERFORANCE DRIVE SE DECISION MADE: 23-JAN-13
NORTH SYRACUSE NY 13212 510(k) STATEMENT
DEVICE: FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K123310(TRADITIONAL)
ATTN: BEN SHIRLEY PHONE NO : 800 533 4984
7043 South 300 West SE DECISION MADE: 23-JAN-13
Midvale UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
SMITH & NEPHEW, INC. 510(k) NO: K123579(SPECIAL)
ATTN: CATHERINE KILSHAW PHONE NO : 508 337 4104
150 MINUTEMAN ROAD SE DECISION MADE: 23-JAN-13
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
ENVITEC-WISMAR GMBH 510(k) NO: K122290(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114
S65 W35739 PIPER ROAD SE DECISION MADE: 23-JAN-13
EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
AUGMENIX , INC. 510(k) NO: K121964(TRADITIONAL)
ATTN: ERIC ANKERUD PHONE NO : 781 902 1613
204 SECOND AVENUE LOWER LEVEL SE DECISION MADE: 23-JAN-13
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOSPEED ANGLED ABUTMENT EV
ASTRA TECH AB 510(k) NO: K121810(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 23-JAN-13
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
ENCORE MEDICAL, L.P. 510(k) NO: K123982(SPECIAL)
ATTN: MICHAELA NORRIS PHONE NO : 512 834 6291
9800 METRIC BLVD. SE DECISION MADE: 23-JAN-13
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF TL-PEEK CAGE
COALIGN INNOVATIONS, INC. 510(k) NO: K123281(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
31 H STREET NW 12TH FLOOR SE DECISION MADE: 23-JAN-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMMA3 AND T2 RECON TARGETING DEVICES
STRYKER TRAUMA AG 510(k) NO: K123401(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461
325 CORPORATE DRIVE SE DECISION MADE: 23-JAN-13
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH 200, LLC 510(k) NO: K123857(TRADITIONAL)
ATTN: LAVENIA FORD PHONE NO : 847 887 3323
1430 WAUKEGAN ROAD SE DECISION MADE: 23-JAN-13
WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
DIAZYME LABORATORIES 510(k) NO: K112120(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 24-JAN-13
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED STEERABLE INTRODUCER
STRYKER SUSTAINABILITY SOLUTIONS, 510(k) NO: K123334(TRADITIONAL)
ATTN: AMANDA BABCOCK PHONE NO : 888 888 3433
10232 S. 51st St. SE DECISION MADE: 24-JAN-13
Phoenix AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
IVOCLAR VIVADENT AG 510(k) NO: K123304(ABBREVIATED)
ATTN: DONNA M HARTNETT PHONE NO : 716 691 2260
175 PINEVIEW DR. SE DECISION MADE: 24-JAN-13
AMHERST NY 14228 510(k) STATEMENT
DEVICE: VITRA MULTISPOT
QUANTEL MEDICAL 510(k) NO: K122251(TRADITIONAL)
ATTN: MAUREEN O’CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 24-JAN-13
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUREFLEX STEERABLE GUIDING SHEATH KIT
BAYLIS MEDICAL CO., INC. 510(k) NO: K122926(TRADITIONAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602487 5
2645 MATHESON BLVD. E SE DECISION MADE: 24-JAN-13
MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POINT 500 HD POINT500C HD
POINTNIX CO., LTD 510(k) NO: K121800(TRADITIONAL)
ATTN: JIGAR SHAH PHONE NO : 516 482 9001
55 NORTHERN BLVD SE DECISION MADE: 24-JAN-13
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASHE SKIN AND WOUND HYDROGEL
PURICORE, INC. 510(k) NO: K123071(TRADITIONAL)
ATTN: ART MORSE PHONE NO : 484 321 2728
508 LAPP ROAD SE DECISION MADE: 24-JAN-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARISTA DIRECT GAS-ASSISTED APPLICATION SYSTEM
MEDAFOR, INC. 510(k) NO: K123325(TRADITIONAL)
ATTN: MELISSA YOUNG PHONE NO : 763 231 8204
2700 FREEWAY BLVD SUITE 800 SE DECISION MADE: 24-JAN-13
MINNEAPOLIS MN 55430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT FN PLUS CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K121455(TRADITIONAL)
ATTN: PATRICIA MURPHY PHONE NO : 919 620 2270
100 RODOLPHE ST SE DECISION MADE: 25-JAN-13
DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
ETHICON ENDO-SURGERY, LLC 510(k) NO: K122797(TRADITIONAL)
ATTN: EMILY KRUETZKAMP PHONE NO : 513 337 1546
4545 CREEK ROAD SE DECISION MADE: 25-JAN-13
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
CODMAN & SHURTLEFF, INC. 510(k) NO: K123560(SPECIAL)
ATTN: RICHARD KIMURA PHONE NO : 408 433 1419
325 PARAMOUNT DR. SE DECISION MADE: 25-JAN-13
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASA LASER SH1
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K122125(TRADITIONAL)
ATTN: PAOLO PERUZZI PHONE NO : 390 558 826807
17 VIA BALDANZESE SE DECISION MADE: 25-JAN-13
CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT PF PLUS CULTURE BOTTLE
BIOMERIEUX, INC. 510(k) NO: K121446(TRADITIONAL)
ATTN: ELIZABETH LANDON PHONE NO : 919 620 2329
100 RODOLPHE ST SE DECISION MADE: 25-JAN-13
DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE METER-CHECK SOLUTION FOR BAYER
BIONOSTICS, INC. 510(k) NO: K123966(TRADITIONAL)
ATTN: RANDY BYRD PHONE NO : 978 862 1830
7 JACKSON RD. SE DECISION MADE: 25-JAN-13
Devens MA 01434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER LED 175
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K123956(TRADITIONAL)
ATTN: SHIVEN GANDHI PHONE NO : 424 218 8322
2151 E. GRAND AVE. SE DECISION MADE: 25-JAN-13
EL SEGUNDO CA 90245 5017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESA615
FLUKE BIOMEDICAL 510(k) NO: K121860(TRADITIONAL)
ATTN: JOHN NELSON PHONE NO : 440 498 2579
6045 COCHRAN RD. SE DECISION MADE: 25-JAN-13
SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZERONA 2.0 LASER
ERCHONIA CORPORATION 510(k) NO: K123237(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412
33 GOLDEN EAGLE LANE SE DECISION MADE: 25-JAN-13
LITTLETON CO 80127 510(k) STATEMENT
DEVICE: 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
SPECTRANETICS CORP. 510(k) NO: K123632(TRADITIONAL)
ATTN: CHRISTINE GODLESKI PHONE NO : 719 447 2414
9665 FEDERAL DRIVE SE DECISION MADE: 25-JAN-13
COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDYSSEY CANNULATED PEDICLE SCREW
MEDYSSEY CO., LTD. 510(k) NO: K121670(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 847 982 0100
8001 N. LINCOLN AVE SUITE 401 SE DECISION MADE: 25-JAN-13
SKOKIE IL 60077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
DIASORIN, INC. 510(k) NO: K122793(TRADITIONAL)
ATTN: JOHN ESKDALE PHONE NO : 651 439 9710
1951 NORTHWESTERN AVE. SE DECISION MADE: 25-JAN-13
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANTOS 3D EAR SCANNER
LANTOS TECHNOLOGIES 510(k) NO: K121326(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954 610 0178
20310 SW 48TH ST SE DECISION MADE: 25-JAN-13
SOUTHWEST RANCHES FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED VESSEL SEALER
STERILMED, INC. 510(k) NO: K123096(TRADITIONAL)
ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483
11400 73RD AVE. NORTH, No. 100 SE DECISION MADE: 25-JAN-13
MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DECLIPSESPECT VIEWER
SURGICEYE GMBH 510(k) NO: K123917(SPECIAL)
ATTN: MORITZ HOYER PHONE NO : 49 89 549989024
Friedenstr. 18a SE DECISION MADE: 25-JAN-13
Munich DE 81671 510(k) STATEMENT
DEVICE: SYSTEM 83 PLUS
CUSTOM ULTRASONICS 510(k) NO: K122172(SPECIAL)
ATTN: FRANK J WEBER PHONE NO : 215 364 1477
144 RAILROAD DR. SE DECISION MADE: 25-JAN-13
IVYLAND PA 18974 510(k) STATEMENT
DEVICE: ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
ESWALLOW USA 510(k) NO: K113375(TRADITIONAL)
ATTN: WILLIAM INGRAM PHONE NO : 256 571 0443
3477 CREEK CIRCLE SE DECISION MADE: 25-JAN-13
GUNTERSVILLE AL 35976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
BIONIME CORPORATION 510(k) NO: K123008(SPECIAL)
ATTN: JIGAR SHAH PHONE NO : 516 482 9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 25-JAN-13
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
SMITH & NEPHEW, INC. 510(k) NO: K123055(TRADITIONAL)
ATTN: BRADLEY HEIL PHONE NO : 901 399 6339
7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 25-JAN-13
CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE NAME
ASSURGUARD SDN. BHD. 510(k) NO: K123760(TRADITIONAL)
ATTN: LIM HUI GUAN PHONE NO : 603 329710 20
82F, JALAN PULASAN KLANG SE DECISION MADE: 28-JAN-13
SELANGOR DARUL EHSAN MY 41000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC. 510(k) NO: K122156(TRADITIONAL)
ATTN: RICHARD KRONENTHAL PHONE NO : 914 357 2600
1 Bridge St Ste 121 SE DECISION MADE: 28-JAN-13
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXERA 2 ACCESS SYSTEM MODEL AXE200
ARSTASIS, INC. 510(k) NO: K123135(TRADITIONAL)
ATTN: DEBRA COGAN PHONE NO : 650 261 8073
740 BAY RD SE DECISION MADE: 28-JAN-13
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC PLUS
MEDTRONIC VASCULAR 510(k) NO: K123358(TRADITIONAL)
ATTN: DIANA JOHNSON PHONE NO : 707 591 2656
3576 UNOCAL PLACE SE DECISION MADE: 29-JAN-13
SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH MCT FAMILY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123737(SPECIAL)
ATTN: ALAINE MEIDO, RAC PHONE NO : 865 218 2703
810 INNOVATION DR. SE DECISION MADE: 29-JAN-13
KNOXVILLE TN 37934 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
ABBOTT VASCULAR INC. 510(k) NO: K123067(TRADITIONAL)
ATTN: SEAN MULLIN PHONE NO : 951 914 3031
P.O. BOX 9018 SE DECISION MADE: 29-JAN-13
TEMECULA CA 92591 9018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARILIFT -C
WENZEL SPINE 510(k) NO: K120603(TRADITIONAL)
ATTN: SOURABH MISHRA PHONE NO : 512 501 4017
206 Wild Basin Road Building A, SuSE DECISION MADE: 29-JAN-13
Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGEQUBE
INTUITIVE IMAGING INFORMATICS, LLC510(k) NO: K124048(TRADITIONAL)
ATTN: CINDY SIMONI PHONE NO : 818 347 8919
30 HACKAMORE LN, SUITE 6 SE DECISION MADE: 29-JAN-13
BELL CANYON CA 91307 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEARTSPAN STEERABLE INTRODUCER KIT
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K122431(TRADITIONAL)
ATTN: TIM STOUDT PHONE NO : 610 651 5000
65 GREAT VALLEY PKWY. SE DECISION MADE: 29-JAN-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
HOLOGIC, INC. 510(k) NO: K123873(TRADITIONAL)
ATTN: DEBORAH THOMAS PHONE NO : 781 999 7558
35 CROSBY DR. SE DECISION MADE: 29-JAN-13
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS ORBITAL PLATES
INION OY 510(k) NO: K122890(TRADITIONAL)
ATTN: KATI MARTTINEN PHONE NO : 358 10 8306611
LAAKARINKATU 2 SE DECISION MADE: 29-JAN-13
TAMPERE FI 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACTUS TISSUEMAPPER REVIEWER APPLICATION
TRACTUS CORPORATION 510(k) NO: K123901(TRADITIONAL)
ATTN: ERIC EGGERS PHONE NO :
981 EL CAJON DR. SUITE 100 SE DECISION MADE: 29-JAN-13
DANVILLE CA 94526 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMMUNOCAP ALLERGEN K82
THERMO FISHER SCIENTIFIC 510(k) NO: K121463(TRADITIONAL)
ATTN: MARTIN MANN PHONE NO : 269 492 1957
4169 COMMERCIAL AVENUE SE DECISION MADE: 29-JAN-13
PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE ECHOPAC
GE VINGMED ULTRASOUND AS 510(k) NO: K123894(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 W INNOVATION DR., RP-2138 SE DECISION MADE: 29-JAN-13
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCEDURE REHEARSAL STUDIO
SIMBIONIX LTD. 510(k) NO: K123269(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092
1914 J.N. PEASE PL. SE DECISION MADE: 29-JAN-13
CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K123444(TRADITIONAL)
ATTN: DAWN TINDALL PHONE NO : 303 581 7034
5920 Longbow Dr SE DECISION MADE: 30-JAN-13
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
GC AMERICA, INC. 510(k) NO: K113816(TRADITIONAL)
ATTN: CARL H JENKINS PHONE NO : 847 234 7500
10 E. SCRANTON AVENUE SUITE 201 SE DECISION MADE: 30-JAN-13
LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
RAYENCE CO., LTD 510(k) NO: K122928(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
12946 KIMBERLEY LN SE DECISION MADE: 30-JAN-13
HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 DENTAL IMPLANT
BIOMET 3I 510(k) NO: K122300(TRADITIONAL)
ATTN: TAMARA WEST PHONE NO : 561 776 3831
4555 RIVERSIDE DR. SE DECISION MADE: 30-JAN-13
Palm Bch Gdns FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
BRANAN MEDICAL CORP. 510(k) NO: K122752(TRADITIONAL)
ATTN: OLIVIA CHAN PHONE NO : 949 598 7166
140 Technology Dr Ste 400 SE DECISION MADE: 30-JAN-13
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
ABBOTT VASCULAR 510(k) NO: K123279(TRADITIONAL)
ATTN: SUZANNE REDMAN PHONE NO : 951 691 3243
26531 YNEZ ROAD P.O. BOX 9018 SE DECISION MADE: 30-JAN-13
TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
FREEDOM MEDITECH, INC. 510(k) NO: K112880(TRADITIONAL)
ATTN: CRAIG H MISRACH PHONE NO : 619 846 6666
10455 PACIFIC CENTER COURT SE DECISION MADE: 31-JAN-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC SCALER
NAKANISHI, INC. 510(k) NO: K113530(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 31-JAN-13
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
COVIDIEN 510(k) NO: K123196(TRADITIONAL)
ATTN: JENNIFER SULLIVAN PHONE NO : 508 452 1659
15 HAMPSHIRE STREET SE DECISION MADE: 31-JAN-13
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
CARDINAL HEALTH, INC. 510(k) NO: K122696(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325
1430 WAUKEGAN ROAD SE DECISION MADE: 31-JAN-13
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DURETTE OCULAR IMPLANT
OCULO-PLASTIK, INC. 510(k) NO: K123764(TRADITIONAL)
ATTN: SYLVAIN DESROSIERS PHONE NO : 514 381 3292
200, RUE SAUVE OUEST SE DECISION MADE: 31-JAN-13
MONTREAL, QC CA H3L 1Y9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X4 SYSTEM
ADVANCED BRAIN MONITORING INC. 510(k) NO: K130013(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023
W324 S3649 COUNTY ROAD E SE DECISION MADE: 31-JAN-13
DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ADVANCE CATHETER FOR HSG AND SIS
CATHETER RESEARCH, INC. 510(k) NO: K123258(SPECIAL)
ATTN: BABACAR DIOUF PHONE NO : 317 872 0074
5610 W 82nd St SE DECISION MADE: 31-JAN-13
INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 TRANSLUMINAL BAV CATHETER
INTERVALVE, INC 510(k) NO: K123111(TRADITIONAL)
ATTN: JULIE BODMER PHONE NO : 612 910 3412
84801 73RD AVENUE NORTH, SUITE 63 SE DECISION MADE: 31-JAN-13
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
WEALTH ON (JIANGSU) CO., LTD 510(k) NO: K122396(TRADITIONAL)
ATTN: CHARLES SHEN PHONE NO : 608 217 9358
5 CAREY ST SE DECISION MADE: 31-JAN-13
PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMINI STERILZATION WRAP
MEDLINE INDUSTRIES, INC. 510(k) NO: K113353(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 31-JAN-13
MUNDELEIN IL 60060 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 218
TOTAL WITH SUMMARIES 204
TOTAL WITH STATEMENTS 14
