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Medical Devices

January 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2013
 
 
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
RAYENCE CO., LTD                  510(k) NO: K122919(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 01-JAN-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA
 
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: A-SCAN PLUS CONNECT
ACCUTOME, INC.                    510(k) NO: K123349(SPECIAL)
ATTN: ADAM  PICKHOLTZ             PHONE NO : 610 889 0200   
3222 Phoenixville Pike            SE DECISION MADE: 29-JAN-13
MALVERN PA 19355                  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: ILUMIEN OPTIS
LIGHTLAB IMAGING, INC.            510(k) NO: K123369(TRADITIONAL)
ATTN: JEFFREY  ROBERTS            PHONE NO : 978 577 3451   
4 ROBBINS ROAD                    SE DECISION MADE: 30-JAN-13
WESTFORD MA 01886                 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: LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
BIO-RAD LABORATORIES              510(k) NO: K123775(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 31-JAN-13
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
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: MULTILINK AUTOMIX
IVOCLAR VIVADENT AG               510(k) NO: K123397(TRADITIONAL)
ATTN: SANDRA  CAKEBREAD           PHONE NO : 423 235 3535   
BENDERERSTRASSE 2                 SE DECISION MADE: 31-JAN-13
SCHAAN    LS FL-9494              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K123691(TRADITIONAL)
ATTN: MURIEL  ASHIE               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 31-JAN-13
MEMPHIS TN 38132                  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   224                                     
                                                 TOTAL WITH SUMMARIES        210                                     
                                                 TOTAL WITH STATEMENTS        14
                                      

 

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