SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2006 THROUGH 31-DEC-2006 DEVICE: COPILOT HEALTY MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. 510(k) NO: K062770(TRADITIONAL)
ATTN: MARY ROSE PHONE NO : 510-239-2634 1360 SOUTH LOOP RD. SE DECISION MADE: 14-DEC-06 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRACOR BALLOON CATHETER ABIOMED, INC. 510(k) NO: K062582(TRADITIONAL)
ATTN: ROBERT T.V. KUNG PHONE NO : 978-646-1440 22 CHERRY HILL DR. SE DECISION MADE: 14-DEC-06 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUGARD MUCOADHESIVE ORAL WOUND RINSE ACCESS PHARMACEUTICALS, INC 510(k) NO: K062795(TRADITIONAL)
ATTN: DAVID NOWOTNIK, PH.D. PHONE NO : 214-905-5100 2600 STEMMONS FREEWAY SE DECISION MADE: 11-DEC-06 SUITE 176 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75207 DEVICE: ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC 510(k) NO: K063460(SPECIAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 07-DEC-06 HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K063080(SPECIAL)
ATTN: AMY CLENDENING PHONE NO : 972-309-8553 6901 PRESTON RD. SE DECISION MADE: 12-DEC-06 PLANO, TX 75024 510(k) STATEMENT DEVICE: ENTEROCOCCUS FAECALIS PNA FISH ADVANDX, INC. 510(k) NO: K063127(TRADITIONAL)
ATTN: AMY AULWES PHONE NO : 781-329-2993 690 CANTON STREET, SUITE 302 SE DECISION MADE: 22-DEC-06 WESTWOOD, MA 02090 510(k) STATEMENT DEVICE: PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S AEARO COMPANY 510(k) NO: K063013(ABBREVIATED)
ATTN: ANN L PHILLIPS PHONE NO : 508-764-5713 90 MECHANIC ST. SE DECISION MADE: 01-DEC-06 SOUTHBRIDGE, MA 01550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM AESCULAP, INC. 510(k) NO: K063017(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 27-DEC-06 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULSKA BETA2-GLYCO-A AESKU, INC 510(k) NO: K062217(TRADITIONAL)
ATTN: DAVID BELL PHONE NO : 323-227-7540 8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 13-DEC-06 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAP III ANTI-SNORING DEVICE AIRWAY MANAGEMENT INC. 510(k) NO: K062951(TRADITIONAL)
ATTN: DARREN HENDERSON PHONE NO : 214-369-0978 6116 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 12-DEC-06 SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75206 DEVICE: BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS AKERS BIOSCIENCES, INC. 510(k) NO: K062971(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 856-848-8698 201 GROVE RD. SE DECISION MADE: 18-DEC-06 THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVIEW ANTERIOR CERVICAL PLATE SYSTEM ALPHASPINE, INC. 510(k) NO: K062371(TRADITIONAL)
ATTN: MIKE ENSIGN PHONE NO : 801-652-6903 765 E 340 S SUITE 204 SE DECISION MADE: 04-DEC-06 AMERICAN FORK, UT 84003-3348 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO AMEDICA BIOTECH, INC. 510(k) NO: K063379(SPECIAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980 28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 11-DEC-06 HAYWARD, CA 94545 510(k) STATEMENT DEVICE: AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 AMEDITECH, INC. 510(k) NO: K063015(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968 10340 CAMINO SANTA FE SE DECISION MADE: 20-DEC-06 SUITE F 510(k) STATEMENT SAN DIEGO, CA 92121 DEVICE: PRN THERMALCARE, MODEL 3000 AMERICAN HEALTHCARE PRODUCTS, INC.510(k) NO: K062794(TRADITIONAL)
ATTN: KENT D ELLIS PHONE NO : 206-721-8029 3220 S. HANFORD STREET SE DECISION MADE: 07-DEC-06 SEATTLE, WA 98144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAMIC GAS SCAVENGING SYSTEM (DGSS) ANESTHETIC GAS RECLAMATION LLC 510(k) NO: K063519(TRADITIONAL)
ATTN: JAMES M BERRY PHONE NO : 615-336-0963 3102 WEST END AVENUE SE DECISION MADE: 01-DEC-06 700 TWO AMERICAN CENTER 510(k) SUMMARY AVAILABLE FROM FDA NASHVILLE, TN 37203 THIRD PARTY REVIEW DEVICE: HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 APEX MEDICAL CORP. 510(k) NO: K062664(TRADITIONAL)
ATTN: ALAN CHANG PHONE NO : 886 2 22683100 NO. 9, MINSHENG STREET SE DECISION MADE: 06-DEC-06 TUCHENG CITY, TAIPEI COUNTY, CHINA510(k) STATEMENT DEVICE: ARC SURGICAL BONE REDUCTION SCREW ARC SURGICAL LLC. 510(k) NO: K063244(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-645-9300 21300 NW JACOBSON RD. SE DECISION MADE: 27-DEC-06 HILLSBORO, OR 97124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URITEST 10 URINALYSIS REAGENT STRIPS ARJ MEDICAL, INC. 510(k) NO: K052719(TRADITIONAL)
ATTN: AARON BEHAR PHONE NO : 727-452-8665 209 STATE STREET SE DECISION MADE: 05-DEC-06 OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARJOWRAP 47/100 AND 47/88 ARJO WIGGINS MEDICAL, INC. 510(k) NO: K062100(SPECIAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 05-DEC-06 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 ARKRAY USA, INC. 510(k) NO: K063068(TRADITIONAL)
ATTN: TOM SPEIKERS PHONE NO : 952-646-3168 5182 WEST 76TH ST. SE DECISION MADE: 20-DEC-06 MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILM DIGITZER, MODEL 2908 MAMMO PRO ARRAY CORP. 510(k) NO: K063424(TRADITIONAL)
ATTN: TAKASHI INAMI PHONE NO : 81 3 33203911 3-42-10 YOYOGI, SHIBUYA-KU SE DECISION MADE: 21-DEC-06 TOKYO, JAPAN 151-0053 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX PUSHLOCK ARTHREX, INC. 510(k) NO: K063479(SPECIAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 13-DEC-06 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT ARTHROCARE CORP. 510(k) NO: K063538(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 01-DEC-06 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIS BILATERAL SENSOR ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K062692(SPECIAL)
ATTN: RENEE GOULD PHONE NO : 617-559-7788 141 NEEDHAM ST. SE DECISION MADE: 13-DEC-06 NEWTON, MA 02464 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE ATLANTIS COMPONENTS, INC. 510(k) NO: K062277(TRADITIONAL)
ATTN: FRANKLIN UYLEMAN PHONE NO : 617-661-9799 25 FIRST ST. SE DECISION MADE: 20-DEC-06 CAMBRIDGE, MA 02141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER ATRIUM MEDICAL CORP. 510(k) NO: K061680(TRADITIONAL)
ATTN: JOSEPH P DEPAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 15-DEC-06 HUDSON, NH 03051 510(k) STATEMENT DEVICE: SUNSPOTS PRE-GELLED SURFACE ELECTRODES AXON SYSTEMS, INC. 510(k) NO: K062198(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112 400-2200 OSER AVE. SE DECISION MADE: 19-DEC-06 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUFFLEX POLYESTER SUTURE AXYA MEDICAL, INC. 510(k) NO: K063194(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 978-232-9997 100 CUMMINGS CENTER SE DECISION MADE: 04-DEC-06 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW BAODING GUANZHONG GLOVE CO., LTD. 510(k) NO: K062714(TRADITIONAL)
ATTN: MARY A DOUCETTE PHONE NO : 760-318-4973 10 SETON COURT SE DECISION MADE: 15-DEC-06 RANCHO MIRAGE, CA 92270 510(k) STATEMENT DEVICE: NIO FUSION 4MP; MDNC 4130 BARCOVIEW 510(k) NO: K062905(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233211 35 PRESIDENT KENNDYPARK SE DECISION MADE: 29-DEC-06 8500 KORTRIJK, BELGIUM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUSCH & LOMB NGX MICROSURGICAL SYSTEM BAUSCH & LOMB, INC. 510(k) NO: K063331(ABBREVIATED)
ATTN: LISA C GRANEY PHONE NO : 585-338-6612 1400 NORTH GOODMAN ST. SE DECISION MADE: 19-DEC-06 ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINITEK ADVANTUS, MODEL 1420 BAYER HEALTHCARE, LLC 510(k) NO: K063276(TRADITIONAL)
ATTN: NOOR MALKI PHONE NO : 781-269-3401 2 EDGEWATER DR. SE DECISION MADE: 28-DEC-06 NORWOOD, MA 02062-4658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64U BECTON, DICKINSON & CO. 510(k) NO: K063301(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938 7 LOVETON CIR. SE DECISION MADE: 08-DEC-06 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASS BIO-RAD LABORATORIES INC., CLINICA510(k) NO: K063643(SPECIAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309 4000 ALFRED NOBEL DR. SE DECISION MADE: 27-DEC-06 HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECT BIO-RAD LABORATORIES, INC. 510(k) NO: K062211(TRADITIONAL)
ATTN: DAVID BHEND PHONE NO : 425-881-8300 6565 185TH AVE., N.E. SE DECISION MADE: 08-DEC-06 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTI BIO-RAD LABORATORIES, INC. 510(k) NO: K062213(TRADITIONAL)
ATTN: DAVID BHEND PHONE NO : 425-881-8300 6565 185TH AVE., N.E. SE DECISION MADE: 08-DEC-06 REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYST BIO-RAD LABORATORIES, INC. 510(k) NO: K063400(SPECIAL)
ATTN: JACKIE BUCKLEY PHONE NO : 510-741-5309 4000 ALFRED NOBEL DR. SE DECISION MADE: 01-DEC-06 HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K063492(TRADITIONAL)
ATTN: JOHN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 21-DEC-06 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR HYBRID GLENOID BIOMET MANUFACTURING CORP. 510(k) NO: K060694(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 11-DEC-06 56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS BIOMET MANUFACTURING CORP. 510(k) NO: K062997(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639 PO BOX 587 SE DECISION MADE: 08-DEC-06 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESA LEADCARE II LEAD CONTROL BIONOSTICS, INC. 510(k) NO: K063398(TRADITIONAL)
ATTN: RANDY BYRD PHONE NO : 978-772-7070 7 JACKSON RD. SE DECISION MADE: 05-DEC-06 DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGE BIOPLATE, INC. 510(k) NO: K062819(TRADITIONAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100 3643 LENAWEE AVE. SE DECISION MADE: 04-DEC-06 LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM BIOPTIGEN, INC. 510(k) NO: K063343(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262 719 A ST. NE SE DECISION MADE: 13-DEC-06 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VISUALASE ENVISION SOFTWARE SYSTEM BIOTEX, INC. 510(k) NO: K063505(TRADITIONAL)
ATTN: MATHEW FOX PHONE NO : 713-741-0111 8058 EL RIO ST. SE DECISION MADE: 12-DEC-06 HOUSTON, TX 77054-4185 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERACAL LC BISCO, INC. 510(k) NO: K063237(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 08-DEC-06 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K062750(TRADITIONAL)
ATTN: ALLYSON BARFORD PHONE NO : 508-683-4356 ONE BOSTON SCIENTIFIC WAY SE DECISION MADE: 04-DEC-06 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) BOSTON SCIENTIFIC CORP. 510(k) NO: K063313(TRADITIONAL)
ATTN: DONNA PAGE PHONE NO : 650-623-1708 2011 STIERLIN CT. SE DECISION MADE: 05-DEC-06 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) BOSTON SCIENTIFIC CORP. 510(k) NO: K063493(SPECIAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 510-624-2461 47900 BAYSIDE PARKWAY SE DECISION MADE: 21-DEC-06 FREMONT, CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTORVISION HIP SR BRAINLAB, AG 510(k) NO: K063028(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 KAPELLENSTR. 12 SE DECISION MADE: 12-DEC-06 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. 510(k) NO: K063446(SPECIAL)
ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 15-DEC-06 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEM CANDELA CORP. 510(k) NO: K063072(TRADITIONAL)
ATTN: JEFFERY ROBERTS PHONE NO : 508-358-7400 530 BOSTON POST ROAD SE DECISION MADE: 20-DEC-06 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEM CANDELA CORP. 510(k) NO: K063073(TRADITIONAL)
ATTN: JEFFERY ROBERTS PHONE NO : 508-358-7400 530 BOSTON POST ROAD SE DECISION MADE: 20-DEC-06 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA 3630 LASER SYSTEM CANDELA CORP. 510(k) NO: K063074(TRADITIONAL)
ATTN: JEFFREY ROBERTS PHONE NO : 508-358-7400 530 BOSTON POST ROAD SE DECISION MADE: 27-DEC-06 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 CARBYLAN BIOSURGERY 510(k) NO: K063308(TRADITIONAL)
ATTN: ROXANNE DUBOIS PHONE NO : 650-855-6775 3181 PORTER DRIVE SE DECISION MADE: 04-DEC-06 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM CARDIVA MEDICAL, INC. 510(k) NO: K051817(TRADITIONAL)
ATTN: KARIN GASTINEAU PHONE NO : 650-504-3903 P.O. BOX 10925 SE DECISION MADE: 06-DEC-06 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORUS LASER KERATOME CARL ZEISS MEDITEC AG 510(k) NO: K062314(TRADITIONAL)
ATTN: KENT W JONES PHONE NO : 925-557-4353 5160 HACIENDA DRIVE SE DECISION MADE: 22-DEC-06 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MODEL 750 SERIES MONITOR CAS MEDICAL SYSTEMS, INC. 510(k) NO: K063087(SPECIAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 11-DEC-06 BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APERFIX TIBIAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. 510(k) NO: K063070(TRADITIONAL)
ATTN: FLOYD LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 14-DEC-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: C-U2 CEFLA S.C.R.L. 510(k) NO: K062897(ABBREVIATED)
ATTN: CLAUDE BERTHOIN PHONE NO : 386-672-0450 110 E GRANADA BLVD. SE DECISION MADE: 14-DEC-06 SUITE 207 510(k) STATEMENT ORMOND BEACH, FL 32176 DEVICE: SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B CEPHEID 510(k) NO: K062948(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408-400-8230 904 CARIBBEAN DRIVE SE DECISION MADE: 08-DEC-06 SUNNYVALE, CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND A CEREMED, INC. 510(k) NO: K062280(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 11-DEC-06 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. 510(k) NO: K062922(SPECIAL)
ATTN: CHRIS SCAVOTTO PHONE NO : 763-463-4621 7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 13-DEC-06 BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC CHI LIN TECHNOLOGY CO., LTD. 510(k) NO: K063579(TRADITIONAL)
ATTN: JUDY LIN PHONE NO : 886 2 26006368 3F, # 86, SEC 1 WUNHUA 1ST RD. SE DECISION MADE: 14-DEC-06 LINKUO, TAIPEI HSIEN, CHINA (TAIWA510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODEL 2200 CLARIMEDEX, INC. 510(k) NO: K062635(TRADITIONAL)
ATTN: JOHN DUNNING PHONE NO : 303-905-6163 1035 PEARL ST. SE DECISION MADE: 19-DEC-06 BOULDER, CO 80302 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COMFORT SCOOTER MODEL LY-EW406 COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K063030(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO.58,FU-CHIUN ST. SE DECISION MADE: 04-DEC-06 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUEHD (1080P) DIGITAL CAMERA SYSTEM CONMED LINVATEC 510(k) NO: K063457(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234 11311 CONCEPT BOULEVARD SE DECISION MADE: 05-DEC-06 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON COOK ENDOSCOPY 510(k) NO: K061937(TRADITIONAL)
ATTN: MABEL L HUNTER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 01-DEC-06 WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIPPER DETACHABLE EMBOLIZATION COILS COOK, INC. 510(k) NO: K063619(SPECIAL)
ATTN: LISA WEBB PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 20-DEC-06 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DE CORDIS NEUROVASCULAR, INC. 510(k) NO: K063254(TRADITIONAL)
ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493 14000 N.W. 57TH CT. SE DECISION MADE: 07-DEC-06 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK DADE BEHRING, INC. 510(k) NO: K062924(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891 P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 26-DEC-06 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATO DADE BEHRING, INC. 510(k) NO: K063206(TRADITIONAL)
ATTN: KATHLEEN DRAY- LYONS PHONE NO : 781-826-4551 GLASGOW SITE SE DECISION MADE: 28-DEC-06 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0 DADE BEHRING, INC. 510(k) NO: K063365(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 2040 ENTERPRISE BLVD. SE DECISION MADE: 08-DEC-06 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNE DADE BEHRING, INC. 510(k) NO: K063366(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-372-1900 2040 ENTERPRISE BLVD. SE DECISION MADE: 08-DEC-06 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. 510(k) NO: K062710(TRADITIONAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 08-DEC-06 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K063478(SPECIAL)
ATTN: RUTH C FOSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DR. SE DECISION MADE: 15-DEC-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062426(SPECIAL)
ATTN: ANNE M SCHULER PHONE NO : 574-372-7098 700 ORTHOPAEDIC DR. SE DECISION MADE: 15-DEC-06 P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: PIPELINE II ACCESS SYSTEM DEPUY SPINE, INC. 510(k) NO: K062814(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 15-DEC-06 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000, IMMULITE 2500 VANCOMYCIN DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K063045(TRADITIONAL)
ATTN: DEBORAH L MORRIS PHONE NO : 310-645-8200 5210 PACIFIC CONCOURCE DR. SE DECISION MADE: 05-DEC-06 LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP DIAGNOSTIC PRODUCTS CORPORATION 510(k) NO: K063057(ABBREVIATED)
ATTN: DEBORAH L MORRIS PHONE NO : 310-645-8200 5210 PACIFIC CONCOURSE DR SE DECISION MADE: 22-DEC-06 LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM DIAGNOSTICA STAGO, INC. 510(k) NO: K061805(TRADITIONAL)
ATTN: LAURA WORFOLK PHONE NO : 973-631-1200 5 CENTURY DR. SE DECISION MADE: 06-DEC-06 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISSION TRINITY B DIAMOND DIAGNOSTICS, INC. 510(k) NO: K062674(TRADITIONAL)
ATTN: RANDOLPH QUINN PHONE NO : 508-429-0450 333 FISKE ST. SE DECISION MADE: 01-DEC-06 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSPLAN / ACCUSOFT-XL V.4.04 DIREX SYSTEMS CORP. 510(k) NO: K063482(SPECIAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013 437 TURNPIKE ST. SE DECISION MADE: 14-DEC-06 CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTIMOL DLC LABORATORIES, INC. 510(k) NO: K061466(TRADITIONAL)
ATTN: JUAN MANZUR PHONE NO : 562-602-2184 7008 MARCELLE STREET SE DECISION MADE: 04-DEC-06 PARAMOUNT, CA 90723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-SCOPE 200 DONGJIN MEDICAL CO., LTD 510(k) NO: K062364(TRADITIONAL)
ATTN: MIN-KANG KIM PHONE NO : 82 31 7779880 #1022 SICOX TOWER, 513-14 SE DECISION MADE: 06-DEC-06 SANGDAEWON-DONG, CHUNGWON-KU 510(k) SUMMARY AVAILABLE FROM FDA SUNGNAM-SI, KYUNGGI-DO, REPUBLIC OF KOREA 462-806 DEVICE: TOTAL AND HEMI SHOULDER SYSTEM DVO EXTREMITY SOLUTIONS, LLC 510(k) NO: K060988(TRADITIONAL)
ATTN: DINA WEISSMAN PHONE NO : 203-736-8631 P.O. BOX 205 SE DECISION MADE: 06-DEC-06 DERBY, CT 06418 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAN ALPHA EASTERN MEDIKIT LTD. 510(k) NO: K063469(TRADITIONAL)
ATTN: RAJEEV ASRI PHONE NO : 91 124 4001831 196, 205 PHASE-1 UDYOG VIHAR SE DECISION MADE: 01-DEC-06 GURAGON, HARYANA, INDIA 122016 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEUROWAVE MICRO-INFUSION SYSTEM EKOS CORP. 510(k) NO: K062508(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132 11911 NORTH CREEK PKWY. SOUTH SE DECISION MADE: 05-DEC-06 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-X EMPATH MEDICAL INCORPORATED 510(k) NO: K063182(TRADITIONAL)
ATTN: JAMES JENKINS PHONE NO : 763-559-2613 15301 HWY. 55 WEST SE DECISION MADE: 21-DEC-06 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-2 ENCORE MEDICAL, L.P. 510(k) NO: K063414(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6225 9800 METRIC BLVD. SE DECISION MADE: 12-DEC-06 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEED VENTRAL PATCH ETHICON, INC. 510(k) NO: K061533(TRADITIONAL)
ATTN: BRYAN A LISA PHONE NO : 908-218-3392 RT. 22 WEST SE DECISION MADE: 11-DEC-06 P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA SOMERVILLE, NJ 08876 DEVICE: EDIA ANTI-CCP EURO-DIAGNOSTICA AB 510(k) NO: K062045(TRADITIONAL)
ATTN: ANNIKA ANDERSSON PHONE NO : 46 40 321155 MEDEON SE DECISION MADE: 04-DEC-06 MALMO, SWEDEN SE-205 12 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K063213(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 05-DEC-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PAT EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K063214(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 08-DEC-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PA EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K063215(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888 3973 SCHAEFER AVE SE DECISION MADE: 08-DEC-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS HC482 DIRECT NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K063036(TRADITIONAL)
ATTN: JAYANTI KARANDIKAR PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 22-DEC-06 EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTI GE HEALTHCARE 510(k) NO: K062324(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 06-DEC-06 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCO GE HEALTHCARE INTEGRATED IT SOLUTI510(k) NO: K063628(TRADITIONAL)
ATTN: KAREN M LUNDE PHONE NO : 847-277-6092 540 W. NW HIGHWAY SE DECISION MADE: 26-DEC-06 BARRINGTON, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL GENTRIS CORPORATION 510(k) NO: K063224(TRADITIONAL)
ATTN: DEBORAH N KLOOS PHONE NO : 919-653-4748 133 SOUTHCENTER CT. SE DECISION MADE: 22-DEC-06 SUITE 400 510(k) STATEMENT MORRISVILLE, NC 27560 DEVICE: CITADEL ANTERIOR LUMBAR PLATE SYSTEM GLOBE MEDICAL, INC. 510(k) NO: K062836(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 19-DEC-06 AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, GRACE MEDICAL, INC. 510(k) NO: K063374(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000 8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 06-DEC-06 MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) HARTALEGA SDN BHD 510(k) NO: K062950(TRADITIONAL)
ATTN: KUAN K HON PHONE NO : 603 627 42177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 21-DEC-06 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: UNISYN HA PLASMA MODULAR HIP HAYES MEDICAL, INC. 510(k) NO: K062383(SPECIAL)
ATTN: LUKE ROSE PHONE NO : 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 21-DEC-06 EL DORADO HILLS, CA 95762-9623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. 510(k) NO: K063612(SPECIAL)
ATTN: ROBIN BUSH PHONE NO : 650-779-9191 2000 SEAPORT BLVD, SUITE 400 SE DECISION MADE: 29-DEC-06 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AN HEARTSINE TECHNOLOGIES, INC. 510(k) NO: K052465(TRADITIONAL)
ATTN: GEORGE BRDLIK PHONE NO : 949-218-0092 105 TERRY DR SE DECISION MADE: 12-DEC-06 NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMIS HEMODIAGNOSTICA, LLC 510(k) NO: K061879(TRADITIONAL)
ATTN: BRUNO BORGANTI PHONE NO : 843-277-1642 130 GARDENERS CIRCLE SE DECISION MADE: 15-DEC-06 JOHNS ISLAND, SC 29455 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HKBOND 2006 HERAEUS KULZER, INC. 510(k) NO: K063062(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 01-DEC-06 SOUTH BEND, IN 46614 510(k) STATEMENT DEVICE: AIR-FLEX WITH AUTO-DISTRACTION HILL LABORATORIES CO. 510(k) NO: K063034(ABBREVIATED)
ATTN: BRADY ALLER PHONE NO : 610-644-2867 3 N. BACTON HILL RD. SE DECISION MADE: 14-DEC-06 FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON MR-RCC-150 CARDIAC COIL HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K063513(ABBREVIATED)
ATTN: DOUGLAS J THISTLEWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 12-DEC-06 TWINSBURG, OH 44080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K063518(SPECIAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 21-DEC-06 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISECURE SYRINGE CARTRIDGE HOLDER HOSPIRA, INC. 510(k) NO: K063180(SPECIAL)
ATTN: DIANE RENNPFERD PHONE NO : 224-212-5452 275 N. FIELD DR., BLDG. H-2 SE DECISION MADE: 11-DEC-06 DEPT. 389 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045 DEVICE: LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODEL HOSPIRA, INC. 510(k) NO: K063239(TRADITIONAL)
ATTN: DIANE RENNPFERD PHONE NO : 224-212-5452 275 NORTH FIELD DR. SE DECISION MADE: 11-DEC-06 DEPT. 389, BLDG. H2 510(k) SUMMARY AVAILABLE FROM FDA LAKE FOREST, IL 60045 DEVICE: TRIDENT II ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K063616(SPECIAL)
ATTN: MANAL MORCOS PHONE NO : 201-831-5020 325 CORPORATE DR. SE DECISION MADE: 20-DEC-06 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR REPLACEMENT ELBOW SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K062845(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DRIVE SE DECISION MADE: 13-DEC-06 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METAIZEAU NAILING SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K063225(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 27-DEC-06 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVLITE Q-SWITCHED ND:YAG LASER HOYA CONBIO, INC 510(k) NO: K063112(SPECIAL)
ATTN: DONNA K TEMPLEMAN PHONE NO : 925-846-0458 1105 SUNSET CREEK LANE SE DECISION MADE: 01-DEC-06 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.T.S. PELVIC RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K063166(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 22-DEC-06 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTISOL ELISA IBL-HAMBURG GMBH 510(k) NO: K062626(TRADITIONAL)
ATTN: VICTOR HERBST PHONE NO : 49 040 5328 FLUGHAFENSTRASSE 52A SE DECISION MADE: 20-DEC-06 HAMBURG, GERMANY D-22335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) IMC-HEARTWAY, LLC 510(k) NO: K063474(ABBREVIATED)
ATTN: MICHAEL CHEN PHONE NO : 866-464-9779 6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 22-DEC-06 FORT MYERS, FL 33912 510(k) STATEMENT DEVICE: IMCO-STAT IMCO TECHNOLOGIES 510(k) NO: K063392(TRADITIONAL)
ATTN: MARK L SCHWARTZ PHONE NO : 262-523-4445 N27 W23957 PAUL RD.,SUITE 101 SE DECISION MADE: 12-DEC-06 PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTON THERAPY SYSTEM INDIANA UNIVERSITY CYCLOTRON FACIL510(k) NO: K062891(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET NW SE DECISION MADE: 14-DEC-06 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 INDITHERM MEDICAL 510(k) NO: K061902(TRADITIONAL)
ATTN: M.W. (ANDY) ANDERSON PHONE NO : 952-746-8079 5353 WAYZATA BLVD. SUITE 505 SE DECISION MADE: 08-DEC-06 MINNEAPOLIS, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOX PEEK VBR SYSTEM INNOVASIS, INC. 510(k) NO: K062151(TRADITIONAL)
ATTN: WARREN M DANSIE PHONE NO : 801-261-2236 614 EAST 3900 SOUTH SE DECISION MADE: 22-DEC-06 SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, L510(k) NO: K062707(TRADITIONAL) ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780 731-733 SHOTGUN RD. SE DECISION MADE: 08-DEC-06 FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS 510(k) NO: K061901(TRADITIONAL)
ATTN: FREDERICK MONTGOMERY PHONE NO : 608-831-4401 7601-B MURPHY DRIVE SE DECISION MADE: 14-DEC-06 MIDDLETON, WI 53562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE INTRINSIC FACTOR ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K061841(TRADITIONAL)
ATTN: GARY L NORMAN PHONE NO : 858-586-9900 9900 OLD GROVE RD. SE DECISION MADE: 22-DEC-06 SAN DIEGO, CA 92131-1638 510(k) STATEMENT DEVICE: QUANTA LITE CELIAC DGP SCREEN INOVA DIAGNOSTICS, INC. 510(k) NO: K062708(TRADITIONAL)
ATTN: DONNA L GUSTAFSON PHONE NO : 858-586-9900 9900 OLD GROVE RD. SE DECISION MADE: 13-DEC-06 SAN DIEGO, CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYST INTAI TECHNOLOGY INC. 510(k) NO: K063020(TRADITIONAL)
ATTN: PIEWEN LIN PHONE NO : 909-605-2700 4230 EAST AIRPORT DRIVE SE DECISION MADE: 14-DEC-06 SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA ONTARIO, CA 91761 DEVICE: MOZAIK BONE REGENERATION MATRIX - PUTTY INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K062353(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-936-2240 311 ENTERPRISE DR. SE DECISION MADE: 20-DEC-06 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA RADIONICS IMAGEFUSION 3 INTEGRA RADIONICS, INC. 510(k) NO: K063230(SPECIAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-565-1227 22 TERRY AVENUE SE DECISION MADE: 21-DEC-06 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WICK ELECTRODE, MODEL M019260 INTELLIGENT HEARING SYSTEMS 510(k) NO: K063402(TRADITIONAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-558-6102 6860 S.W. 81ST ST. SE DECISION MADE: 11-DEC-06 MIAMI, FL 33143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT DATA HANDLER & DEVICES (PDH&D) INTERMED ADVISORS, INC. 510(k) NO: K063484(TRADITIONAL)
ATTN: CHRISTINA VULLO PHONE NO : 781-648-4935 828 MASSACHUSETTS AVENUE SE DECISION MADE: 22-DEC-06 ARLINGTON, MA 02476 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 INTUITIVE SURGICAL, INC. 510(k) NO: K063220(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100 950 KIFER RD. SE DECISION MADE: 01-DEC-06 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSTAR OIA SHIGATOX INVERNESS MEDICAL-BIOSTAR INC. 510(k) NO: K061889(TRADITIONAL)
ATTN: ROBIN C HART PHONE NO : 303-530-6612 331 SOUTH 104TH ST. SE DECISION MADE: 12-DEC-06 LOUISVILLE, CO 80516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBDERMAL WIRE ELECTRODE, MODEL SWE IVES EEG SOLUTIONS, INC. 510(k) NO: K062880(TRADITIONAL)
ATTN: JOHN R IVES PHONE NO : 613 692 1567 6325 RIDEAU VALLEY DRIVE SE DECISION MADE: 22-DEC-06 MANOTICK, ONTARIO, CANADA K4M 1B3 510(k) STATEMENT DEVICE: BAND-AID(R) BRAND LIQUID BANDAGE JOHNSON & JOHNSON CONSUMER COMPANI510(k) NO: K062602(TRADITIONAL)
ATTN: MICHELLE R TURK PHONE NO : 908-904-3723 199 GRANDVIEW ROAD SE DECISION MADE: 11-DEC-06 SKILLMAN, NJ 08558-9498 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, KCI USA, INC. 510(k) NO: K063426(SPECIAL)
ATTN: VERONIQUE SMITH PHONE NO : 210-255-6739 8023 VANTAGE DR. SE DECISION MADE: 13-DEC-06 SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K062965(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-793-0484 2530 RIVA ROAD SE DECISION MADE: 22-DEC-06 SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA ANNAPOLIS, MD 21401 DEVICE: KOWA SL-15 KOWA CO. LTD. 510(k) NO: K063640(SPECIAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : 81 332 797329 4-14, NIHONBASHI-HONCHO SE DECISION MADE: 18-DEC-06 3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA CHUO-KU, TOKYO, JAPAN 103-8433 DEVICE: SURFACE COAT KURARAY AMERICA, INC. 510(k) NO: K063228(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230 600 LEXINGTON AVE. SE DECISION MADE: 08-DEC-06 26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10022 DEVICE: LASER-D68 LASER PAIN CLINICS LP 510(k) NO: K061656(TRADITIONAL)
ATTN: HOLLY WRIGHT PHONE NO : 903-868-1350 300 N. HIGHLAND, SUITE 105 SE DECISION MADE: 15-DEC-06 SHERMAN, TX 75092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE 510(k) NO: K062719(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 800-243-9384 3070 ORCHARD DR. SE DECISION MADE: 01-DEC-06 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BF+ (PH) LDR SPINE USA 510(k) NO: K061462(SPECIAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-344-3316 4030 WEST BRAKER LANE SE DECISION MADE: 15-DEC-06 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: DPILOG, MODEL DPC-512 LIFE OUTCOMES, INC. 510(k) NO: K062811(TRADITIONAL)
ATTN: CHARLES M HART PHONE NO : 303-358-9302 3957 BLUE PINE CIRCLE SE DECISION MADE: 20-DEC-06 HIGHLANDS RANCH, CO 80126-8077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LSC, MODEL 3 LIFESTAND 510(k) NO: K061726(TRADITIONAL)
ATTN: STEFANIE D BANKSTON PHONE NO : 409-995-0741 2611 SHARK CIRCLE SE DECISION MADE: 04-DEC-06 TEXAS CITY, TX 77591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,50 LINA MEDICAL APS 510(k) NO: K063025(TRADITIONAL)
ATTN: WALT BRITTLE PHONE NO : 919-942-1634 1289 N. FORDHAM BLVD. SUITE A- SE DECISION MADE: 01-DEC-06 128 510(k) STATEMENT CHAPEL HILL, NC 27517 DEVICE: RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K063140(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000 40 PARKER SE DECISION MADE: 29-DEC-06 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: SMITHWICK CAROTID SHUNT MCPHERSON ENTERPRISES, INC. 510(k) NO: K061484(SPECIAL)
ATTN: WILLIAM MCPHERSON PHONE NO : 813-310-7921 P.O. BOX 270882 SE DECISION MADE: 07-DEC-06 TAMPA, FL 33688 510(k) STATEMENT DEVICE: SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K063580(TRADITIONAL)
ATTN: KYUNG-AM SHIM PHONE NO : 82 2 21941381 1003, DAECHI-DONG SE DECISION MADE: 14-DEC-06 GANGNANM-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW DEVICE: MEDLINE STERILE DISPOSABLE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. 510(k) NO: K062969(SPECIAL)
ATTN: LARA N SIMMONS PHONE NO : 847-837-2759 ONE MEDLINE PL. SE DECISION MADE: 14-DEC-06 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: LIFEPAK 20 DEFIBRILLATOR/ MONITOR MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K063119(SPECIAL)
ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744 11811 WILLOWS RD., N.E. SE DECISION MADE: 22-DEC-06 P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: U-CLIP DEVICE MEDTRONIC NEUROSURGERY 510(k) NO: K062821(TRADITIONAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 19-DEC-06 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX DBM PUTTY AND PASTE MEDTRONIC SOFAMOR DANEK 510(k) NO: K060794(TRADITIONAL)
ATTN: EDWARD S CHIN PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-DEC-06 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC GRAFT DELIVERY SYRINGE MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K062986(TRADITIONAL)
ATTN: EDWARD S CHIN PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 08-DEC-06 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K062879(TRADITIONAL)
ATTN: ED CHIN PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 22-DEC-06 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCATOR MICROSYRINGE II INFUSION CATHETER MERCATOR MEDSYSTEMS, INC. 510(k) NO: K062752(TRADITIONAL)
ATTN: KIRK SEWARD PHONE NO : 510-614-4555 3077 TEAGARDEN STREET SE DECISION MADE: 07-DEC-06 SAN LEANDRO, CA 94577-5720 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ENA CEM MICERIUM S.P.A. 510(k) NO: K062355(TRADITIONAL)
ATTN: EUGENIO MICELI PHONE NO : 39 018 57887870 VIA MARCONI 83 SE DECISION MADE: 27-DEC-06 AVENGO, ITALY 16030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISCREWS ANCHORING SYSTEM, M.A.S. MICERIUM S.P.A. 510(k) NO: K062367(TRADITIONAL)
ATTN: EUGENIO MICELI PHONE NO : 39 018 57887870 VIA MARCONI 83 SE DECISION MADE: 08-DEC-06 AVENGO, ITALY 16030 510(k) STATEMENT DEVICE: CT COMPATIBLE F/S/D APPLICATORS MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K063381(TRADITIONAL)
ATTN: FLEIX MICK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 22-DEC-06 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDR CT COMPATIBLE SPLIT RING APPLICATORS, MODEL 0605 MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K063382(TRADITIONAL)
ATTN: FELIX MICK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 26-DEC-06 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULMOLIFE MICRO MEDICAL, LTD. 510(k) NO: K061283(TRADITIONAL)
ATTN: GLEN HILLSLEY PHONE NO : 011 44 1634893500 QUAYSIDE SE DECISION MADE: 14-DEC-06 CHATHAM MARITIME 510(k) SUMMARY AVAILABLE FROM FDA CHATHAM, KENT, UNITED KINGDOM ME4 4QY DEVICE: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K062867(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 06-DEC-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERDRY TEXTILE WITH SILVER MILLIKEN CHEMICAL 510(k) NO: K061615(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 22-DEC-06 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) MILTEX, INC. 510(k) NO: K061033(TRADITIONAL)
ATTN: CHARLES WEAVER PHONE NO : 717-840-3422 589 DAVIES DRIVE SE DECISION MADE: 12-DEC-06 YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTAX LASER SHOT SYSTEM MINITUBE OF AMERICA, INC 510(k) NO: K062524(ABBREVIATED)
ATTN: FREDERICK KIKKERS PHONE NO : 608-848-6350 419 VENTURE COURT SE DECISION MADE: 15-DEC-06 VERONA, WI 53593 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROBANK II MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K061712(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 390 622 754777 VIA DEL MAGGIOLINO 125 SE DECISION MADE: 01-DEC-06 ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINISPIR; SPIROLAB III MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K061875(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777 VIA DEL MAGGIOLINO 125 SE DECISION MADE: 11-DEC-06 ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGEL ECLIPSE INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K062847(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930 5550 PEACHTREE PARKWAY SE DECISION MADE: 20-DEC-06 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA NORCROSS, GA 30092 DEVICE: MOONCUP MOONCUP LIMITED 510(k) NO: K060852(TRADITIONAL)
ATTN: SU HARDY PHONE NO : 440 127 3673845 DOLPHIN HOUSE SE DECISION MADE: 26-DEC-06 40 ARUNDEL STREET 510(k) STATEMENT BRIGHTON, UNITED KINGDOM BN2 1GD DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K053218(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-0202 125 MAY STREET SE DECISION MADE: 28-DEC-06 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NFIX II PEDICLE SCREW SYSTEM N SPINE, INC. 510(k) NO: K061774(TRADITIONAL)
ATTN: R. STEPHEN REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 13-DEC-06 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NCONTACT COAGULATION SYSTEM KIT NCONTACT SURGICAL, INC. 510(k) NO: K062539(TRADITIONAL)
ATTN: JANE RICUPERO PHONE NO : 919-466-9810 2880 SLATER ROAD SE DECISION MADE: 01-DEC-06 SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: NCONTACT COAGULATION SYSTEM KIT, MODEL CSK NCONTACT SURGICAL, INC. 510(k) NO: K063012(TRADITIONAL)
ATTN: JANE RICUPERO PHONE NO : 919-466-9810 2880 SLATER ROAD SE DECISION MADE: 01-DEC-06 SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 NEUROVIRTUAL USA, INC. 510(k) NO: K062533(TRADITIONAL)
ATTN: EDUARDO FARIA PHONE NO : 305-767-2870 2335 NW 107TH AVE. SE DECISION MADE: 22-DEC-06 B. 133 - WH.B49/50 510(k) SUMMARY AVAILABLE FROM FDA DORAL, FL 33172 DEVICE: HUMERUS LOCKING PLATING SYSTEM NEWCLIP TECHNICS 510(k) NO: K063095(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 22-DEC-06 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDWEB ADVANCED 3D WEB PACS NEXSYS ELECTRONICS, INC. 510(k) NO: K063221(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 12-DEC-06 SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS IRRIGATION TUBING SET NEXUS MEDICAL, LLC 510(k) NO: K062551(TRADITIONAL)
ATTN: ANITA SMITH PHONE NO : 913-451-2234 11315 STRANG LINE ROAD SE DECISION MADE: 15-DEC-06 LENEXA, KS 66215 510(k) STATEMENT DEVICE: CARBON DIOXIDE MONITOR, MODEL OLG-2800A NIHON KOHDEN AMERICA, INC. 510(k) NO: K062115(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 27-DEC-06 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPERFECT CONICAL CONNECTION NOBEL BIOCARE AB 510(k) NO: K062936(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 19-DEC-06 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELREPLACE TAPERED CONICAL CONNECTION NOBEL BIOCARE USA LLC 510(k) NO: K062566(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074 22715 SAVI RANCH PARKWAY SE DECISION MADE: 06-DEC-06 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULOC BREAST LOCALIZATION SYSTEM NORTHWEST MEDICAL PHYSICS EQUIPMEN510(k) NO: K063274(TRADITIONAL)
ATTN: LEE MYERS PHONE NO : 425-672-2841 21031 67TH AVE. WEST SE DECISION MADE: 12-DEC-06 LYNNWOOD, WA 98036 510(k) STATEMENT DEVICE: NOVAPACS NOVARAD CORP. 510(k) NO: K063153(TRADITIONAL)
ATTN: PAUL SHUMWAY PHONE NO : 801-642-1001 758 EAST UTAH VALLEY DR. SE DECISION MADE: 07-DEC-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA AMERICAN FORK, UT 84003 DEVICE: ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K062517(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 22-DEC-06 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: ORI F6T DRY ECG MONITORING ELECTRODE ORBITAL RESEARCH INC. 510(k) NO: K062760(TRADITIONAL)
ATTN: AARON ROOD PHONE NO : 216-649-0399 4415 EUCLID AVE. SE DECISION MADE: 11-DEC-06 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA CLEVELAND, OH 44103-3733 DEVICE: TF ROTARY NICKEL TITANIUM FILE ORMCO CORP. 510(k) NO: K062856(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766 100 BAYVIEW CIRCLE SE DECISION MADE: 13-DEC-06 SUITE 6000 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT BEACH, CA 92660 DEVICE: VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K062838(TRADITIONAL)
ATTN: CHARLOTTE BAKER PHONE NO : 585-453-3730 100 INDIGO CREEK DR. SE DECISION MADE: 19-DEC-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CA ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062285(TRADITIONAL)
ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 22-DEC-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K062460(TRADITIONAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041 100 INDIGO CREEK DR. SE DECISION MADE: 15-DEC-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CA ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K063143(TRADITIONAL)
ATTN: CHARLOTTE BAKER PHONE NO : 585-453-3730 100 INDIGO CREEK DR. SE DECISION MADE: 26-DEC-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CAL ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K063164(TRADITIONAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143 100 INDIGO CREEK DR. SE DECISION MADE: 28-DEC-06 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHE ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K063591(SPECIAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143 100 INDIGO CREEK DRIVE SE DECISION MADE: 15-DEC-06 MC881 510(k) SUMMARY AVAILABLE FROM FDA ROCHESTER, NY 14626-5101 DEVICE: O&P BIVALVE CRANIAL MOLDING HELMET ORTHOTIC & PROSTHETIC LAB, INC. 510(k) NO: K063395(TRADITIONAL)
ATTN: THOMAS L MALONE PHONE NO : 314-968-8555 748 MARSHALL AVE. SE DECISION MADE: 22-DEC-06 WEBSTER GROVES, MO 63119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSPRAY CLEANING COMPOUND OSPRAY, LTD. 510(k) NO: K062502(TRADITIONAL)
ATTN: CARMELINA G ALLIS PHONE NO : 202-737-9634 700 THIRTEENTH STREET NW SE DECISION MADE: 15-DEC-06 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: ABC HAIR REMOVAL SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K060839(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414 82 CAMBRIDGE ST. SE DECISION MADE: 07-DEC-06 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K061436(TRADITIONAL)
ATTN: SHARON L TIMBERLAKE PHONE NO : 781-993-2414 82 CAMBRIDGE ST. SE DECISION MADE: 06-DEC-06 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELERITY PARKELL, INC. 510(k) NO: K062518(TRADITIONAL)
ATTN: NELSON J GENDUSA PHONE NO : 631-249-1134 300 EXECUTIVE DR. SE DECISION MADE: 04-DEC-06 EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITHODIAMOND ULTRA PCK ELECTRONIC INDUSTRY & TRADE CO510(k) NO: K061350(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 22-DEC-06 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD PENG LIM ENTERPRISE CO., LTD. 510(k) NO: K062947(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU-CHIUN STREET SE DECISION MADE: 14-DEC-06 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYSTOGLIDE INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INCORPORATED510(k) NO: K052298(TRADITIONAL)
ATTN: THOMAS LAWSON PHONE NO : 650-969-8800 1300 CRITTENDEN LANE SE DECISION MADE: 12-DEC-06 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA MOUNTAIN VIEW, CA 94043-1359 DEVICE: K-Y BRAND INTRIGUE PERSONAL PRODUCTS CO. 510(k) NO: K062796(TRADITIONAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730 199 GRANDVIEW RD. SE DECISION MADE: 08-DEC-06 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MO PHADIA US INC. 510(k) NO: K062583(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957 4169 COMMERCIAL AVE. SE DECISION MADE: 26-DEC-06 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MO PHADIA US INC. 510(k) NO: K062787(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957 4169 COMMERCIAL AVE. SE DECISION MADE: 29-DEC-06 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUMIMED PHOTOACTIF, LLC 510(k) NO: K060792(TRADITIONAL)
ATTN: JEREMY SHELLMAN PHONE NO : 480-827-1212 1959 SOUTH POWER RD SE DECISION MADE: 01-DEC-06 SUITE 103-313 510(k) SUMMARY AVAILABLE FROM FDA MESA, AZ 85206 DEVICE: FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (N PRAESIDIA S.R.L. 510(k) NO: K063009(TRADITIONAL)
ATTN: GEORGE HAAR PHONE NO : 716-883-8097 1083 DELAWARE AVE. SE DECISION MADE: 27-DEC-06 BUFFALO, NY 14209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, BLACK PT. MAJA AGUNG LATEXINDO 510(k) NO: K062709(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIEL ST. SE DECISION MADE: 06-DEC-06 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA QUEST DIAGNOSTICS, INC. 510(k) NO: K062929(TRADITIONAL)
ATTN: LIUMING YU PHONE NO : 913-895-2305 10101 RENNER BLVD. SE DECISION MADE: 18-DEC-06 LENEXA, KS 66219-9752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 RADI MEDICAL SYSTEMS AB 510(k) NO: K062769(SPECIAL)
ATTN: MATS GRANLUND PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 04-DEC-06 UPPSALA, SWEDEN SE-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REST ASSURED NITE PROTECTOR RANIR LLC 510(k) NO: K063229(TRADITIONAL)
ATTN: CHRISTOPHER PREDKO PHONE NO : 616-752-2190 900 FIFTH THIRD CENTER SE DECISION MADE: 19-DEC-06 111 LYON STREET N.W. 510(k) SUMMARY AVAILABLE FROM FDA GRAND RAPIDS, MI 49503 DEVICE: RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-0 RAYNER SURGICAL INC 510(k) NO: K062612(TRADITIONAL)
ATTN: MARK MULLANEY PHONE NO : 441 273 205401 SACKVILLE ROAD SE DECISION MADE: 13-DEC-06 HOVE, EAST SUSSEX, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XCEL 255 SLIT LAMP REICHERT INC. 510(k) NO: K063750(TRADITIONAL)
ATTN: SANDRA BROWN PHONE NO : 716-686-4500 3362 WALDEN AVE. SE DECISION MADE: 20-DEC-06 DEPEW, NY 14043 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: LOSS OF RESISTANCE SYRINGE ROBERT BUSSE & CO., INC. 510(k) NO: K061737(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711 P.O. BOX 11067 SE DECISION MADE: 18-DEC-06 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL ROCHE DIAGNOSTICS CORP. 510(k) NO: K063543(SPECIAL)
ATTN: CORINA HARPER PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 22-DEC-06 P.O. BOX 50416 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS ROSTAM LTD. 510(k) NO: K062001(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201 327 0035 73 FRANKLIN TPK. SE DECISION MADE: 07-DEC-06 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTI SCANDIUS BIOMEDICAL, INC. 510(k) NO: K063497(SPECIAL)
ATTN: RALPH ZIMMERMAN PHONE NO : 978-486-4088 11A BEAVER BROOK ROAD SE DECISION MADE: 19-DEC-06 LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. 510(k) NO: K063499(SPECIAL)
ATTN: RALPH ZIMMERMAN PHONE NO : 978-486-4088 11A BEAVER BROOK ROAD SE DECISION MADE: 19-DEC-06 LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M-BOLUS EMBOLIC MICROSPHERES SCION CARDIO-VASCULAR, INC. 510(k) NO: K052509(ABBREVIATED)
ATTN: SUZANA OTANO-LATA PHONE NO : 305-259-8880 14256 SW 119TH AVE. SE DECISION MADE: 11-DEC-06 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHANGHAI GANGHAI MODEL GIKO 1400 SHANGHAI GANGKAI PURIFYING PRODUCT510(k) NO: K063334(ABBREVIATED)
ATTN: JOSEPH Z ZDROK PHONE NO : 772-778-0240 7380 36TH COURT SE DECISION MADE: 08-DEC-06 VERO BEACH, FL 32967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUIKE, MODEL 3431 SHANGHAI RUIKE SPORTS GOODS CO., L510(k) NO: K062645(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396 14F-2, NO.1, LANE 25 SE DECISION MADE: 19-DEC-06 ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220 DEVICE: RUIKE, MODEL 3331 SHANGHAI RUIKE SPORTS GOODS CO., L510(k) NO: K062676(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396 14F-2, NO.1, LANE 25 SE DECISION MADE: 14-DEC-06 ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220 DEVICE: VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K063055(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 21-DEC-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K063500(TRADITIONAL)
ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 06-DEC-06 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MOBIS SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K061082(SPECIAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873 4050 OLSON MEMORIAL HWY SE DECISION MADE: 18-DEC-06 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: ALLERGEAZE PATCH TEST CHAMBERS SMART PRACTICE 510(k) NO: K063160(TRADITIONAL)
ATTN: KIM SULLIVAN PHONE NO : 602-225-0595 3400 EAST MCDOWELL RD. SE DECISION MADE: 22-DEC-06 PHOENIX, AZ 85008 510(k) STATEMENT DEVICE: RCHIVE PACS SOBHA RENAISSANCE INFORMATION TECH510(k) NO: K063253(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 12-DEC-06 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANEX NOVUS SOREDEX PALODEX GROUP OY 510(k) NO: K063459(TRADITIONAL)
ATTN: KAI LANER PHONE NO : 358 457 8822000 NAHKELANTIE 160 SE DECISION MADE: 26-DEC-06 TUUSULA, FINLAND 00430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEEDLELESS SLING SPECIALITIES REMEEX INTERNATIONAL,510(k) NO: K063136(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952 835 4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 19-DEC-06 EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SSP VERTEBRAL BODY REPLACEMENT SPECIALTY SPINE PRODUCTS, LLC 510(k) NO: K061578(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 26-DEC-06 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: APEX SPINE SYSTEM SPINECRAFT, INC. 510(k) NO: K062513(TRADITIONAL)
ATTN: AMI AKALLAL-ASAAD PHONE NO : 708-531-9700 2215 ENTERPRISE DRIVE SE DECISION MADE: 22-DEC-06 SUITE 1504 510(k) SUMMARY AVAILABLE FROM FDA WESTCHESTER, IL 60154 DEVICE: REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS SPIRE BIOMEDICAL, INC. 510(k) NO: K062435(TRADITIONAL)
ATTN: SHEKHAR NIMKAR PHONE NO : 781-275-6001 ONE PATRIOTS PARK SE DECISION MADE: 05-DEC-06 BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAIMAD STEVEN LAMBERG, D.D.S 510(k) NO: K062333(ABBREVIATED)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN STREET, NW SE DECISION MADE: 14-DEC-06 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOFIT STRATEGIC COUNSEL SARL 510(k) NO: K060795(ABBREVIATED)
ATTN: JOHN DENNIS PHONE NO : 703-777-8404 42754 EDWARDS FERRY ROAD SE DECISION MADE: 18-DEC-06 LEESBURG, VA 20176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CHECK (XE) STRECK 510(k) NO: K063218(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215 7002 SOUTH 109TH ST. SE DECISION MADE: 14-DEC-06 OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 STRYKER INSTRUMENTS 510(k) NO: K062640(TRADITIONAL)
ATTN: BECKEY DITTY PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 14-DEC-06 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA STAINLESS STEEL SPINAL SYSTEM STRYKER SPINE 510(k) NO: K063428(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 11-DEC-06 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTA AVS SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K063600(TRADITIONAL)
ATTN: KEN JARRELL PHONE NO : 303-423-7572 4620 TECHNOLOGY DR. UNIT 100 SE DECISION MADE: 19-DEC-06 GOLDEN, CO 80403 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LOGIC LAPAROSCOPIC SCISSORS SURGICAL INNOVATIONS PLC 510(k) NO: K063485(TRADITIONAL)
ATTN: STUART MORAN PHONE NO : 44 0 1132200328 CLAYTON PARK SE DECISION MADE: 01-DEC-06 CLAYTON WOOD RISE 510(k) SUMMARY AVAILABLE FROM FDA LEEDS, UNITED KINGDOM LS16 6RF THIRD PARTY REVIEW DEVICE: CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM SWISS MEDICAL CARE S.A. 510(k) NO: K062265(TRADITIONAL)
ATTN: ROBERT AROMANDO PHONE NO : 908-751-1818 32 STRATTON COURT SE DECISION MADE: 26-DEC-06 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEMETRON A.2 SYBRON DENTAL SPECIALTIES 510(k) NO: K063116(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766 100 BAYVIEW CIRCLE SE DECISION MADE: 05-DEC-06 SUITE 6000 510(k) SUMMARY AVAILABLE FROM FDA NEWPORT BEACH, CA 92660-8915 DEVICE: VERITAS COLLAGEN MATRIX SYNOVIS SURGICAL INNOVATIONS 510(k) NO: K062915(TRADITIONAL)
ATTN: CYNTHIA LAMARUCCIOLA PHONE NO : 651-796-7372 2575 UNIVERSITY AVE. SE DECISION MADE: 06-DEC-06 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM SYNTHES (USA) 510(k) NO: K063049(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610-719-6948 1301 GOSHEN PKWY SE DECISION MADE: 18-DEC-06 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COM TANITA CORPORATION OF AMERICA 510(k) NO: K062652(TRADITIONAL)
ATTN: BETH MACKEY PHONE NO : 847-640-9241 2625 SOUTH CLEARBROOK DRIVE SE DECISION MADE: 28-DEC-06 ARLINGTON HEIGHTS, IL 60005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP. 510(k) NO: K063613(SPECIAL)
ATTN: SANDI HARTKA PHONE NO : 410-392-7243 950 ELKTON BLVD. SE DECISION MADE: 26-DEC-06 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER THE HYMED GROUP CORP. 510(k) NO: K061227(SPECIAL)
ATTN: ANITA PETITO PHONE NO : 610-865-9876 1890 BUCKNELL DR. SE DECISION MADE: 20-DEC-06 BETHLEHEM, PA 18015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE P THE SMITHWORKS COMPANY 510(k) NO: K060851(TRADITIONAL)
ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733 2615 102ND AVE NE SE DECISION MADE: 22-DEC-06 BELLEVUE, WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS RESURFACING HEAD TORNIER 510(k) NO: K062661(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898 161 RUE LAVOISIER SE DECISION MADE: 22-DEC-06 MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS HUMERAL PLATE TORNIER 510(k) NO: K063551(SPECIAL) ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898 161 RUE LAVOISIER SE DECISION MADE: 22-DEC-06 MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA SAINT-ISMIER CEDEX, FRANCE 38334 DEVICE: 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) TOTOKU ELECTRIC CO., LTD 510(k) NO: K063199(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA SE DECISION MADE: 04-DEC-06 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) TOTOKU ELECTRIC CO., LTD 510(k) NO: K063200(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA SE DECISION MADE: 07-DEC-06 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUS TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K062841(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 20-DEC-06 CLEVELAND, OH 44131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC TZ MEDICAL, INC. 510(k) NO: K062577(TRADITIONAL)
ATTN: MADALYN DUNCAN PHONE NO : 503-639-0282 7272 S.W. DURHAM RD., #800 SE DECISION MADE: 15-DEC-06 PORTLAND, OR 97224 510(k) STATEMENT DEVICE: LUXVISION SLIT LAMP U.S. OPHTHALMIC LLC 510(k) NO: K063416(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437 7255 NW 68 ST. UNIT #9 SE DECISION MADE: 07-DEC-06 MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBELISC VERTEBRAL BODY REPLACEMENT DEVICE ULRICH GMBH & CO. KG 510(k) NO: K060416(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 727-797-4727 2519 MCMULLEN BOOTH ROAD SE DECISION MADE: 26-DEC-06 SUITE 510-295 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: PEAK BOND, MODEL 5133 ULTRADENT PRODUCTS, INC. 510(k) NO: K063557(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491 505 WEST 10200 SOUTH SE DECISION MADE: 12-DEC-06 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEAK SE, MODEL 5135 ULTRADENT PRODUCTS, INC. 510(k) NO: K063558(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491 505 WEST 10200 SOUTH SE DECISION MADE: 14-DEC-06 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CITRIC ACID 20% SOLUTION, MODEL 329 ULTRADENT PRODUCTS, INC. 510(k) NO: K063703(SPECIAL)
ATTN: COREY JASEPH PHONE NO : 800-552-5512 505 WEST 10200 SOUTH SE DECISION MADE: 21-DEC-06 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: USI DENTAL SCALER, 25XXX SERIES ULTRASONIC SERVICES INC. 510(k) NO: K062791(TRADITIONAL)
ATTN: JAMES FEINE PHONE NO : 713-665-4949 7126 MULLINS DRIVE SE DECISION MADE: 11-DEC-06 HOUSTON, TX 77081 510(k) STATEMENT DEVICE: ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM ULTRAZONIX DNT AB 510(k) NO: K060346(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018 7307 GLOUCHESTER DRIVE SE DECISION MADE: 22-DEC-06 EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLIMATOR, MODEL M-38 UMI INTERNATIONAL 510(k) NO: K062788(TRADITIONAL)
ATTN: KWANG C JUNG PHONE NO : 201-784-2950 129 KENSINGTON AVE. SE DECISION MADE: 28-DEC-06 NORWOOD, NJ 07648 510(k) STATEMENT DEVICE: RIGIDOMETER, MODEL DIR-4U UROAN 21 510(k) NO: K061676(TRADITIONAL)
ATTN: ANABEL ROSSELLO PHONE NO : 12 ANSELM TURMEDA SE DECISION MADE: 27-DEC-06 PALMA DE MALLORCA, SPAIN 07003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTD POLYAXIAL FIXATION SYSTEM US SPINE 510(k) NO: K062785(SPECIAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999 13540 GUILD AVE SE DECISION MADE: 26-DEC-06 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-PROX ENDOSCOPIC GRASPER USGI MEDICAL 510(k) NO: K061276(TRADITIONAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890 1140 CALLE CORDILLERA SE DECISION MADE: 06-DEC-06 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RPM RESPIRATORY GATING SYSTEM VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K063270(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 14-DEC-06 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONTO V3 EXTRACTION CATHETER, MODEL 5003 VASCULAR SOLUTIONS, INC. 510(k) NO: K063371(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228 6464 SYCAMORE COURT NORTH SE DECISION MADE: 14-DEC-06 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT VERIDEX, LLC 510(k) NO: K062013(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-791-2438 33 TECHNOLOGY DR. SE DECISION MADE: 14-DEC-06 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-MIO, EZ-IO DISTAL TIBIA VIDACARE CORPORATION 510(k) NO: K062956(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 05-DEC-06 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUAL PD-IO; POWERED PD-IO VIDACARE CORPORATION 510(k) NO: K063142(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 08-DEC-06 IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTE VIRTUAL IMAGING 510(k) NO: K063262(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 26-DEC-06 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G VISGENEER, INC. 510(k) NO: K062555(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 27-DEC-06 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPAL-RAD VIZTEK, INC. 510(k) NO: K063337(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 12-DEC-06 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIC BOND VOCO GMBH 510(k) NO: K062345(TRADITIONAL)
ATTN: MICHAEL SUES PHONE NO : 49 472 1719214 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 15-DEC-06 CUXHAVEN, GERMANY D-27472 510(k) STATEMENT DEVICE: FLOSIMPLE ARTHROSCOPY PUMP A120 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K062380(SPECIAL)
ATTN: SUSANNE RAAB PHONE NO : 617-547-0628 1490 CAMBRIDGE STREET SE DECISION MADE: 14-DEC-06 CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE INJECTION GUN (B.I.G.) WAISMED LTD. 510(k) NO: K062940(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5910 555 THIRTEENTH STREET, NW SE DECISION MADE: 22-DEC-06 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWIST DRILL WALTER LORENZ SURGICAL, INC. 510(k) NO: K062842(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 04-DEC-06 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ STERNAL CLOSURE SYSTEM WALTER LORENZ SURGICAL, INC. 510(k) NO: K063506(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 18-DEC-06 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) WELCH ALLYN PROTOCOL, INC. 510(k) NO: K063419(SPECIAL)
ATTN: JEFFREY WAGNER PHONE NO : 503-530-7909 8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 04-DEC-06 BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM WITT BIOMEDICAL CORP 510(k) NO: K063547(SPECIAL)
ATTN: JAMES LUKER PHONE NO : 321-253-5693 305 NORTH DR. SE DECISION MADE: 21-DEC-06 MELBOURNE, FL 32934 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K061844(SPECIAL) ATTN: MATT PAUL PHONE NO : 901-867-4350 5677 AIRLINE RD. SE DECISION MADE: 06-DEC-06 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSERVE FEMORAL RESURFACING COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K062960(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 01-DEC-06 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-STEN MILD TOOL KIT, MODEL MTK-0001 X-STEN CORP. 510(k) NO: K062038(TRADITIONAL)
ATTN: TIMOTHY M REEVES PHONE NO : 408-427-3101 2362 QUME DRIVE SE DECISION MADE: 19-DEC-06 SUITE D 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95131-1841 DEVICE: VASCUTRAK PTA DILATION CATHETER YMED INC. 510(k) NO: K063657(TRADITIONAL)
ATTN: THOMAS SCHROEDER PHONE NO : 714-290-5720 9925B BUSINESS PARK AVENUE SE DECISION MADE: 12-DEC-06 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 ZIMMER, INC. 510(k) NO: K061461(SPECIAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354 P.O. BOX 708 SE DECISION MADE: 20-DEC-06 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOPULSE RESUSCITATION SYSTEM MODEL100 ZOLL CIRCULATION 510(k) NO: K063602(SPECIAL)
ATTN: MARK PERKINS PHONE NO : 408-541-2140 249 HUMBOLDT COURT SE DECISION MADE: 21-DEC-06 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL E SERIES WITH REAL CPR HELP ZOLL MEDICAL CORPORATION 510(k) NO: K062177(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386 269 MILL ROAD SE DECISION MADE: 13-DEC-06 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 283 TOTAL WITH SUMMARIES 256 TOTAL WITH STATEMENTS 27
Updated January 5, 2007
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