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Medical Devices
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December 2006 510(k) Clearances
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
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