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Home » FDA releases January 510(k) clearances

FDA releases January 510(k) clearances

February 6, 2013 By MassDevice staff

FDA logo

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

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Center for Devices and Radiological Health (CDRH)

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  • MMI debuts robotic surgery instruments, digital surgery platform
  • Synchrony Medical wins FDA nod for airway clearance system

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