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510(k)s Final Decisions Rendered for September 1999 |
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DEVICE: DOUBLE LUMEN NEEDLE INTL., INC. 510(k) NO: K991020(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 09-SEP-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERM WASHING MEDIA INTL., INC. 510(k) NO: K991022(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 09-SEP-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE:SINGLE LUMEN NEEDLE INTL., INC. 510(k) NO: K991262(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 09-SEP-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE LUMEN SIDEPORT NEEDLE INTL., INC. 510(k) NO: K991264(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 09-SEP-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYO TRANSFER CATHETER CC GLIDER INTL., INC. 510(k) NO: K991266(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD., UNIT 14 SE DECISION MADE: 09-SEP-99 MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE A&D MEDICAL DIV. 510(k) NO: K992808(TRADITIONAL) ATTN: JERRY WANG PHONE NO : 408-263-5333 1555 MCCANDLESS DRIVE SE DECISION MADE: 01-SEP-99 MILPITAS, CA 95025 510(k) STATEMENT DEVICE: SYNEA-HS HIGH SPEED-HANDPIECE A-DEC, INC. 510(k) NO: K992011(TRADITIONAL) ATTN: PATRICK RIDENOUR PHONE NO : 503-537-2756 2601 CRESTVIEW DR. SE DECISION MADE: 10-SEP-99 NEWBERG, OR 97132-9257 510(k) STATEMENT DEVICE: MAGNESIUM PRODUCT NO'S, 112-01, 112-02 A.P. TOTAL CARE, INC. 510(k) NO: K991761(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 02-SEP-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT 06606 DEVICE: ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 A.P. TOTAL CARE, INC. 510(k) NO: K991762(TRADITIONAL) ATTN: LUIS P LEON PHONE NO : 203-335-9277 70 HAWLEY AVE, SE DECISION MADE: 02-SEP-99 PO BOX 6216 510(k) STATEMENT BRIDGEPORT, CT 06606 DEVICE: FUTURA GLASS IONOMER SILVER REINFORCED AB ARDENT 510(k) NO: K991974(TRADITIONAL) ATTN: CLYDE E INGERSOLL PHONE NO : 716-693-6591 54 RIVERVIEW AVENUE SE DECISION MADE: 17-SEP-99 TONAWANDA, NY 14150-5260 510(k) STATEMENT DEVICE: MODIFICATION OF: CELL-DYN 1200 SYSTEM ABBOTT LABORATORIES, INC. 510(k) NO: K992444(TRADITIONAL) ATTN: JANICE E BROWN PHONE NO : 408-567-3521 5440 PATRICK HENRY DR. SE DECISION MADE: 24-SEP-99 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUIMAGE DIAGNOSTICS CORP. 510(k) NO: K990241(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 23-SEP-99 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTICAL MAPPING UNIT, MODEL CMU AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K992194(TRADITIONAL) ATTN: JOHN F ZIOBRO PHONE NO : 414-634-1555 1901 WILLIAM STREET SE DECISION MADE: 13-SEP-99 RACINE, WI 53404-1876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE EXSPECT II ADAC LABORATORIES 510(k) NO: K992078(TRADITIONAL) ATTN: GENINE M GRANT PHONE NO : 408-468-3989 540 ALDER DR. SE DECISION MADE: 01-SEP-99 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-1 ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K990867(TRADITIONAL) ATTN: SANDRA SUNDELL PHONE NO : 408-835-4278 3200 LAKESIDE DRIVE SE DECISION MADE: 02-SEP-99 SANTA CLARA, CA 95052-8167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENEW RECEIVER ADVANCED NEUROMODULATION SYSTEMS, 510(k) NO: K992946(SPECIAL) ATTN: KATRYNA WARREN PHONE NO : 972-309-8000 6501 WINDCREST DR., SUITE 100 SE DECISION MADE: 24-SEP-99 PLANO, TX 75024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH ADVANCED REPRODUCTIVE TECHNOLOGIES510(k) NO: K991378(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 24-SEP-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: REDI-TEST OPIATES ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K991883(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 3573 WESTWIND BLVD SE DECISION MADE: 15-SEP-99 SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP ALCON LABORATORIES 510(k) NO: K984573(TRADITIONAL) ATTN: RALPH H LARSEN PHONE NO : 817-551-4702 6201 SOUTH FREEWAY SE DECISION MADE: 16-SEP-99 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CO ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K992171(TRADITIONAL) ATTN: ERICA SETHI PHONE NO : 847-785-3337 1500 WAUKEGAN ROAD BUILDING K SE DECISION MADE: 14-SEP-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K992951(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 22-SEP-99 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PYLON INTRAMEDULLAARY NAIL SYSTEM ALPHATEC MFG., INC. 510(k) NO: K992350(TRADITIONAL) ATTN: JASON BLAIN PHONE NO : 760-779-8250 42-160 STATE ST. SE DECISION MADE: 22-SEP-99 PALM DESERT, CA 92211-5148 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-18 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992565() ATTN: LARS-OLOF SANDBERG PHONE NO : 464-577-5900 FRIDHEMSVAGEN 15 SE DECISION MADE: 23-SEP-99 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-15 HEMODIALYZER ALTHIN MEDICAL AB 510(k) NO: K992594(TRADITIONAL) ATTN: LARS-OLOF SANDBERG PHONE NO : 46 457 75900 FRIDHEMSVAGEN 15 SE DECISION MADE: 24-SEP-99 RONNEBY, SWEDEN S-37221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 AMBA MEDICAL LTD. 510(k) NO: K990253(TRADITIONAL) ATTN: MIKE CAUDWELL PHONE NO : 011 44 1179728888 BONVILLE ROAD SE DECISION MADE: 24-SEP-99 BRISLINGTON 510(k) STATEMENT BRISTOL BS4 5QH, UNITED KINGDOM BS4 5QH DEVICE: DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE AMERITEK, INC. 510(k) NO: K990873(TRADITIONAL) ATTN: K.C. YEE PHONE NO : 206-527-5086 7030 35TH AVE., N.E. SE DECISION MADE: 01-SEP-99 SEATTLE, WA 98115 510(k) STATEMENT DEVICE: AMPLAID A724 AND A728 AMPLIFON S.P.A. 510(k) NO: K992370(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 20-SEP-99 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC. 510(k) NO: K991540(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 29-SEP-99 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: UROLOGICAL CATHETER APOGEE, INC. 510(k) NO: K992137(TRADITIONAL) ATTN: BRENT D ROBLING PHONE NO : 919-596-4761 7517-101 PRECISION DR. SE DECISION MADE: 03-SEP-99 RALEIGH, NC 27613 510(k) STATEMENT DEVICE: FLEXIBLADE ARCO MEDIC LTD. 510(k) NO: K984101(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 771 8130 117 AHUZAH ST. SE DECISION MADE: 03-SEP-99 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERLON WOUND PACKING STRIPS ARGENTUM INTERNATIONAL LLC 510(k) NO: K984210(TRADITIONAL) ATTN: A. BART FLICK PHONE NO : 706-782-6700 PO BOX 429 SE DECISION MADE: 24-SEP-99 LAKEMONT, GA 30552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, ARTHROCARE CORP. 510(k) NO: K992972(SPECIAL) ATTN: BETTY M JOHNSON PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 24-SEP-99 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AVANTI POLAR LIPIDS, INC. 510(k) NO: K992124(TRADITIONAL) ATTN: ROWENA SHAW PHONE NO : 205-663-2494 700 INDUSTRIAL PARK DR. SE DECISION MADE: 20-SEP-99 ALABASTER, AL 35007-9105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) AXYA MEDICAL, INC. 510(k) NO: K992405(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 22-SEP-99 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP. 510(k) NO: K992399(TRADITIONAL) ATTN: GABRIEL J MURACAA JR PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 15-SEP-99 TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAR CUB 750 PSV BEAR MEDICAL SYSTEMS, INC. 510(k) NO: K992788(SPECIAL) ATTN: DARRYL SHELBY PHONE NO : 800-232-7633 1100 BIRD CENTER DR. SE DECISION MADE: 16-SEP-99 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE BECTON DICKINSON & CO. 510(k) NO: K991551(TRADITIONAL) ATTN: JAMES W HAYNES PHONE NO : 201-847-5170 1 BECTON DRIVE SE DECISION MADE: 23-SEP-99 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM BECTON DICKINSON & CO. 510(k) NO: K992849(SPECIAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIRCLE SE DECISION MADE: 23-SEP-99 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE BEST MFG. CO. 510(k) NO: K992170(TRADITIONAL) ATTN: DAVID C YOUNG PHONE NO : 706-862-2302 579 EDISON STREET SE DECISION MADE: 07-SEP-99 MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-LOGIC EVOKED POTENTIAL FOR ABAER I BIO-LOGIC SYSTEMS CORP. 510(k) NO: K992807(SPECIAL) ATTN: NORMAN E BRUNNER PHONE NO : 800-323-8326 ONE BIO-LOGIC PLAZA SE DECISION MADE: 14-SEP-99 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 BIO-PLEXUS, INC. 510(k) NO: K992091(TRADITIONAL) ATTN: PAUL A TENTHOREY PHONE NO : 860-870-6112 129 RESERVOIR RD. SE DECISION MADE: 09-SEP-99 VERNON, CT 06066-5705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 BIO-RAD LABORATORIES, INC. 510(k) NO: K992172(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 02-SEP-99 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCHECK FERRITIN ELISA MODEL BC-1025 BIOCHECK, INC. 510(k) NO: K992517(TRADITIONAL) ATTN: ROBIN HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 24-SEP-99 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: BIOCHECK IGE ELISA, MODEL BC-1035 BIOCHECK, INC. 510(k) NO: K992528(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 21-SEP-99 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: TWILIGHT BIOLASE TECHNOLOGY, INC. 510(k) NO: K991994(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 10-SEP-99 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO RIMMED ACETABULAR COMPOMENT BIOLOGICALLY ORIENTED PROSTHESES 510(k) NO: K992144(TRADITIONAL) ATTN: ANGENA PAREKH PHONE NO : 810-982-7777 17 SEVENTEENTH ST. SE DECISION MADE: 22-SEP-99 PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUNITE SCREWS BIOMET MANUFACTURING, INC. 510(k) NO: K992301(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 01-SEP-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: TRI-POLAR SYSTEM BIOMET, INC. 510(k) NO: K991990(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 10-SEP-99 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIO-MODULAR SHOULDER SYSTEM BIOMET, INC. 510(k) NO: K992119(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 13-SEP-99 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLOR BUFFED CEMENTED FEMORAL BIOMET, INC. 510(k) NO: K992903(SPECIAL) ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-372-1612 P.O. BOX 587 SE DECISION MADE: 17-SEP-99 AIRPORT INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: CANNULATED SMARTSCREW MODELS 224540C, 224570C BIONX IMPLANTS, LTD. 510(k) NO: K992947(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 P.O. BOX 3 SE DECISION MADE: 21-SEP-99 HERMINKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA TAMPERE, FINLAND FIN-33720 DEVICE: CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) BIOPRO (M) SDN BHD 510(k) NO: K992358(TRADITIONAL) ATTN: JIM LALE PHONE NO : 603 376 1390 LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 10-SEP-99 HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT PORT KLANG, DELANGOR, MALAYSIA 42000 DEVICE: CARTO EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. 510(k) NO: K992968(SPECIAL) ATTN: SANDRA WILLIAMSON PHONE NO : 800-729-9010 3333 DIAMOND CANYON RD. SE DECISION MADE: 29-SEP-99 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF NOGA BIOSENSE, INC. 510(k) NO: K990494(SPECIAL) ATTN: MARCIA LEATHAM PHONE NO : 626-939-8843 3333 DIAMOND CANYON RD. SE DECISION MADE: 03-SEP-99 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: @ TARGET BRAINLAB GMBH 510(k) NO: K983410(TRADITIONAL) ATTN: PHONE NO : 3100 HANSEN WAY SE DECISION MADE: 17-SEP-99 BUILDING 4A, MAILSTOP E233 510(k) STATEMENT POLO ALTO, CA 94304 DEVICE: BROADLINE OR TOWELS BROADLINE MEDICAL INDUSTRIES 510(k) NO: K991667(TRADITIONAL) ATTN: ANNA M RAMZA PHONE NO : 847-359-4231 1432 SHIRE CIRCLE SE DECISION MADE: 27-SEP-99 INVERNESS, IL 60067 510(k) STATEMENT DEVICE: BARD BALLOON INFLATION SYSTEM C.R. BARD, INC. 510(k) NO: K991375(TRADITIONAL) ATTN: MARION GORDON PHONE NO : 978-262-4867 129 CONCORD RD., BLDG. 3 SE DECISION MADE: 10-SEP-99 BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALTAG FETAL HEMOGLOBIN TEST CALTAG LABORATORIES, INC. 510(k) NO: K990641(TRADITIONAL) ATTN: DAVID C BISHOP PHONE NO : 610-942-0219 605 DILWORTH ROAD SE DECISION MADE: 17-SEP-99 DOWNINGTOWN, PA 19335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOCARDIOGRAPHY SYSTEM SERIES 95000 CAMTRONICS, LTD. 510(k) NO: K992259(TRADITIONAL) ATTN: ROBERT KRIEDERMANN PHONE NO : 414-367-0700 MEDICAL SYSTEMS SE DECISION MADE: 08-SEP-99 900 WALNUT RIDGE DR. 510(k) SUMMARY AVAILABLE FROM FDA HARTLAND, WI 53029 DEVICE: CARESIDE CO2, TOTAL CARESIDE, INC. 510(k) NO: K992475(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 15-SEP-99 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D10 810NM DIODE LASER CERAMOPTEC, INC. 510(k) NO: K992773(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 01-SEP-99 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 CHOLESTECH CORP. 510(k) NO: K991834(TRADITIONAL) ATTN: THOMAS E WORTHY PHONE NO : 510-293-8002 3347 INVESTMENT BLVD. SE DECISION MADE: 09-SEP-99 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM CLINICON INC. 510(k) NO: K992472(TRADITIONAL) ATTN: GERALD S PALECKI PHONE NO : 760-930-0010 5825 AVENIDA ENCINAS SE DECISION MADE: 08-SEP-99 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOOTHE-N-SEAL CANKER SORE RELIEF CLOSURE MEDICAL CORP. 510(k) NO: K991923(TRADITIONAL) ATTN: W. THOMAS STEPHENS PHONE NO : 919-877-2112 5250 GREENS DAIRY RD. SE DECISION MADE: 02-SEP-99 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE H COBE CARDIOVASCULAR, INC. 510(k) NO: K991986(TRADITIONAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 09-SEP-99 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K992440(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 21-SEP-99 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: COLLINS CPL COLLINS MEDICAL, INC. 510(k) NO: K992743(SPECIAL) ATTN: DALE F HUBBARD PHONE NO : 781-843-0610 220 WOOD RD. SE DECISION MADE: 13-SEP-99 BRAINTREE, MA 02184-2408 510(k) STATEMENT DEVICE: FRESH AIR COLORADO MEDTECH, INC. 510(k) NO: K981047(TRADITIONAL) ATTN: LOCKETT E WOOD PHONE NO : 303-530-2626 6175 LONGBOW DR. SE DECISION MADE: 16-SEP-99 BOULDER, CO 80301 510(k) STATEMENT DEVICE: IS H. PYLORI IGG ELISA TEST SYSTEM COLUMBIA BIOSCIENCE, INC. 510(k) NO: K990462(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-1278 8775 M CENTRE PARK DR. SE DECISION MADE: 03-SEP-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: MUMPS IGG ELISA TEST SYSTEM COLUMBIA BIOSCIENCE, INC. 510(k) NO: K991274(TRADITIONAL) ATTN: NORMAN JENKINS PHONE NO : 410-995-1278 8775 M CENTRE PARK DR. SE DECISION MADE: 03-SEP-99 #559 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: URINE CHEMISTRY CONTROL, LEVEL 1 CONSOLIDATED TECHNOLOGIES INC. 510(k) NO: K992576(TRADITIONAL) ATTN: RUSTY SEWELL PHONE NO : 512-445-5100 2170 WOODWARD ST. SE DECISION MADE: 03-SEP-99 STE 100 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744-1832 DEVICE: URINE CHEMISTRY CONTROL, LEVEL 2 CONSOLIDATED TECHNOLOGIES INC. 510(k) NO: K992578(TRADITIONAL) ATTN: RUSTY SEWELL PHONE NO : 512-445-5100 2170 WOODWARD ST. SE DECISION MADE: 03-SEP-99 STE 100 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744-1832 DEVICE: DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER CONTINUUM BIOMEDICAL, INC. 510(k) NO: K992013(TRADITIONAL) ATTN: LAURIE A RIDENER PHONE NO : 510-828-3210 6533 SIERRA LANE SE DECISION MADE: 08-SEP-99 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 CONWAY STUART MEDICAL, INC. 510(k) NO: K991529(TRADITIONAL) ATTN: DAVID A TUCKER PHONE NO : 408-733-9910 735 PALOMAR ST. SE DECISION MADE: 14-SEP-99 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGISIS SLING COOK BIOTECH, INC. 510(k) NO: K992159(TRADITIONAL) ATTN: NEAL E FEARNOT PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 23-SEP-99 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS EXTREME PTA BALLOON CATHETER CORDIS CORP. 510(k) NO: K992825(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 40 TECHNOLOGY DR. SE DECISION MADE: 15-SEP-99 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILITY STEERABLE GUIDEWIRE CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K991646(TRADITIONAL) ATTN: MARITZA CELAYA PHONE NO : 305-512-6546 14000 N.W. 57TH CT. SE DECISION MADE: 23-SEP-99 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY CORDIS, A JOHNSON & JOHNSON CO. 510(k) NO: K992190(TRADITIONAL) ATTN: THOMAS M MCINTOSH PHONE NO : 904-641-6611 11222 ST. JOHNS IND. PKWY. SE DECISION MADE: 01-SEP-99 NORTH 510(k) STATEMENT JACKSONVILLE, FL 32246-6675 DEVICE: CORE AUDIBLE TROCAR II CORE DYNAMICS, INC. 510(k) NO: K992250(TRADITIONAL) ATTN: THOMAS M MCINTOSH PHONE NO : 904-641-6611 11222 ST. JOHNS IND. PKWY. SE DECISION MADE: 24-SEP-99 NORTH 510(k) STATEMENT JACKSONVILLE, FL 32246-6675 DEVICE: ENDO-SPOR PLUS / HYPROCIDE COTTRELL, LTD. 510(k) NO: K972708(TRADITIONAL) ATTN: JACK SCOVILLE PHONE NO : 303-799-9401 7399 SOUTH TUCSON WAY SE DECISION MADE: 13-SEP-99 ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE DIODERM CYNOSURE, INC. 510(k) NO: K992765(TRADITIONAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 08-SEP-99 CHELMSFORD, MA 01824 510(k) STATEMENT DEVICE: CYNOSURE ACCOLADE LASER CYNOSURE, INC. 510(k) NO: K992814(SPECIAL) ATTN: GEORGE CHO PHONE NO : 508-256-4200 10 ELIZABETH DR. SE DECISION MADE: 15-SEP-99 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 DADE BEHRING, INC. 510(k) NO: K992321(TRADITIONAL) ATTN: RANDAMES RIESGO PHONE NO : 305-636-7727 1851 DELAWARE PKWY. SE DECISION MADE: 17-SEP-99 MIAMI, FL 33125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 DADE BEHRING, INC. 510(k) NO: K992423(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-636-7727 1851 DELAWARE PKWY. SE DECISION MADE: 21-SEP-99 MIAMI, FL 33125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 DADE BEHRING, INC. 510(k) NO: K992763(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-636-7727 1851 DELAWARE PKWY. SE DECISION MADE: 21-SEP-99 MIAMI, FL 33125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GL DASH MEDICAL GLOVES SDN BHD 510(k) NO: K992128(TRADITIONAL) ATTN: ROBERT J SULLIVAN JR PHONE NO : 414-421-2229 10180 SOUTH 54TH STREET SE DECISION MADE: 14-SEP-99 FRANKLIN, WI 53132 510(k) STATEMENT DEVICE: STATVIEW SYSTEM DATA CRITICAL CORP. 510(k) NO: K990378(TRADITIONAL) ATTN: DREW WEAVER PHONE NO : 425-482-7000 19820 NORTH CREEK PARKWAY SE DECISION MADE: 20-SEP-99 # 100 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98011 DEVICE: DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO DAVOL, INC., SUB. C.R. BARD, INC. 510(k) NO: K991799(TRADITIONAL) ATTN: LUCINDA L FOX PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 13-SEP-99 CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR DENPLUS INC. 510(k) NO: K991996(TRADITIONAL) ATTN: SHUOJIA DONG PHONE NO : 450 646 1330 4235 BEACONSFIELD SE DECISION MADE: 08-SEP-99 MONTREAL, QUEBEC, CANADA H4A 2H4 510(k) STATEMENT DEVICE: DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, DENTAL X-RAY SUPPORT SYSTEMS, INC.510(k) NO: K992896(TRADITIONAL) ATTN: JUM JACOBSON PHONE NO : 425-640-0926 2124 - 196TH ST. S.W., SUITE B SE DECISION MADE: 03-SEP-99 LYNNWOOD, WA 98036-7006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENZIR DENTRONIC AB 510(k) NO: K984201(TRADITIONAL) ATTN: ANDERS SUNDH PHONE NO : 46 910 83570 BOX 733 SE DECISION MADE: 29-SEP-99 931 27 SKELLETTEA, SWEDEN 931 27 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTL. 510(k) NO: K992518(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 22-SEP-99 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENDEX 765DC, MODEL 110-0154 DENTSPLY INTL. 510(k) NO: K992610(TRADITIONAL) ATTN: DANIEL P MURPHY PHONE NO : 847-640-4908 901 WEST OAKTON ST. SE DECISION MADE: 07-SEP-99 DES PLAINES, IL 60018-1884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSS MIAMI 6.35MM POLYAXIAL SCREW DEPUY ACROMED 510(k) NO: K992168(TRADITIONAL) ATTN: FRANK MAAS PHONE NO : 508-828-3390 325 PARAMOUNT DRIVE SE DECISION MADE: 23-SEP-99 RAYHNAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STACKABLE CAGE SYSTEM DEPUY MOTECH ACROMED 510(k) NO: K990148(TRADITIONAL) ATTN: WILLIAM CHRISTIANSON PHONE NO : 216-431-9900 325 PARAMOUNT DRIVE SE DECISION MADE: 03-SEP-99 RAYHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS DERMAPHYLYX, INC. 510(k) NO: K992302(TRADITIONAL) ATTN: ANDREW M REED PHONE NO : 303-431-6796 12106, WEST 75TH LANE SE DECISION MADE: 14-SEP-99 ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K990212(TRADITIONAL) ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422 143 WOLCOTT RD. SE DECISION MADE: 14-SEP-99 WOLCOTT, CT 06716 510(k) STATEMENT DEVICE: PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) DYNAMIC SYSTEMS, INC. 510(k) NO: K991090(TRADITIONAL) ATTN: DAVID R COURT PHONE NO : 770-939-1122 5002 N. ROYAL ATLANTA DR., #P SE DECISION MADE: 24-SEP-99 TUCKER, GA 30084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOFLOW DOPPLER BLOOD VELOCITY METER ECHOCATH, INC. 510(k) NO: K990642(TRADITIONAL) ATTN: GEPRGE MYERS PHONE NO : 201-727-1703 4326 U.S. ROUTE #1 SE DECISION MADE: 16-SEP-99 MONMOUTH JUNCTION, NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS ELECTRO-BIOLOGY, INC. 510(k) NO: K992367(TRADITIONAL) ATTN: JONAS WILF PHONE NO : 973-299-9022 100 INTERPACE PARKWAY SE DECISION MADE: 23-SEP-99 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,E ELEKTA INSTRUMENT AB 510(k) NO: K992882(SPECIAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 24-SEP-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUPEL IONTOPHORESIS SYSTEM EMPI, INC. 510(k) NO: K991991(TRADITIONAL) ATTN: KRISTY K MOLLNER PHONE NO : 651-415-7389 599 CARDIGAN RD. SE DECISION MADE: 10-SEP-99 ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS SUCTION/IRRIGATION INSTRUMENT ENDIUS INC. 510(k) NO: K992535(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 01-SEP-99 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINFONY ESPE DENTAL AG 510(k) NO: K992645(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 22-SEP-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPREGUM F ESPE DENTAL AG 510(k) NO: K992895(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 08-SEP-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPREGUM PENTA ESPE DENTAL AG 510(k) NO: K992897(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 08-SEP-99 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRUMENT, ULTRASONIC, SCALPEL ETHICON ENDO-SURGERY, INC. 510(k) NO: K990362(TRADITIONAL) ATTN: RUTH ANN WOOD PHONE NO : 513-483-3468 4545 CREEK RD. SE DECISION MADE: 17-SEP-99 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKETSPACER FERRARIS MEDICAL, INC. 510(k) NO: K992038(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 09-SEP-99 WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCHOELLY RIGID ENDOSCOPES FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K992437(TRADITIONAL) ATTN: JOSEPH RESS PHONE NO : 617-965-7714 45 PONTIAC ROAD SE DECISION MADE: 14-SEP-99 NEWTON, MA 02468 510(k) STATEMENT DEVICE: BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE FORMOSA GLOVE INDUSTRIAL CO., LTD.510(k) NO: K992588(TRADITIONAL) ATTN: TIANG S CHANG PHONE NO : 908-233-3571 1016 SEWARD AVE. SE DECISION MADE: 10-SEP-99 WESTFIELD, NJ 07090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS BLOOD VOLUME MONITOR FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K982926(TRADITIONAL) ATTN: DONALD A LINCOLN PHONE NO : 508-384-2546 10 OAK POINT SE DECISION MADE: 03-SEP-99 WRENTHAM, MA 02093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COROMETRICS MODEL 171 AND 172 FETAL MONITOR GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991905(TRADITIONAL) ATTN: RICHARD CEHOVSKY PHONE NO : 203-949-8320 61 BARNES PARK ROAD NORTH SE DECISION MADE: 01-SEP-99 WALLINGFORD, CT 06492-0333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC. 510(k) NO: K992135(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 08-SEP-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DIASONICS GATEWAY AND GATEWAY FX GENERAL ELECTRIC CO. 510(k) NO: K993069(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 22-SEP-99 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTU GENZYME SURGICAL PRODUCTS CORP. 510(k) NO: K992088(TRADITIONAL) ATTN: MARY E GRAY PHONE NO : 508-677-6512 600 AIRPORT RD. SE DECISION MADE: 03-SEP-99 FALL RIVER, MA 02722-2980 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GILTECH PLUS TRANSPARENT DRESSING GILTECH PLUS, INC. 510(k) NO: K992005(TRADITIONAL) ATTN: WILLIAM J GILIAM PHONE NO : 717-686-4184 P.O. BOX 728 SE DECISION MADE: 03-SEP-99 MILFORD, PA 18337 510(k) STATEMENT DEVICE: GILTECH PLUS HYDROGEL SKIN DRESSING GILTECH PLUS, INC. 510(k) NO: K992094(TRADITIONAL) ATTN: WILLIAM J GILIAM PHONE NO : 570-686-4184 P.O. BOX 728 SE DECISION MADE: 17-SEP-99 MILFORD, PA 18337 510(k) STATEMENT DEVICE: HAMILTON MEDICAL GALILEOVENTILATOR HAMILTON MEDICAL, INC. 510(k) NO: K982910(TRADITIONAL) ATTN: J. DAVID THOMPSON PHONE NO : 800-426-6331 505 EDISON WAY SE DECISION MADE: 14-SEP-99 RENO, NV 89502 510(k) STATEMENT DEVICE: SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K992839(TRADITIONAL) ATTN: DAGMAR S MAESER PHONE NO : AMSTEL 320-I SE DECISION MADE: 16-SEP-99 AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACID HEMOGLOBIN KIT HELENA LABORATORIES 510(k) NO: K992199(TRADITIONAL) ATTN: PAT FRANKS PHONE NO : 800-231-5663 1530 LINDBERGH DR. SE DECISION MADE: 21-SEP-99 BEAUMONT, TX 77704 510(k) STATEMENT DEVICE: BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) HEMOCLEANSE, INC. 510(k) NO: K992196(SPECIAL) ATTN: STEPHEN R ASH PHONE NO : 765-463-9540 2700 KENT AVE. SE DECISION MADE: 10-SEP-99 WEST LAFAYETTE, IN 47906 510(k) STATEMENT DEVICE: EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2 HOLOGIC, INC. 510(k) NO: K992677(SPECIAL) ATTN: NANDINI MURTHY PHONE NO : 781-999-7300 35 CROSBY DR. SE DECISION MADE: 03-SEP-99 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM HOME DIAGNOSTICS, INC. 510(k) NO: K992988(SPECIAL) ATTN: KAREN DEVINCENT PHONE NO : 800-342-7226 24OO N.W. 55TH CT. SE DECISION MADE: 24-SEP-99 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY HOWMEDICA OSTEONICS CORP. 510(k) NO: K992063(TRADITIONAL) ATTN: MARYBETH NAUGHTON PHONE NO : 201-934-4376 59 ROUTE 17 SE DECISION MADE: 03-SEP-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE HOWMEDICA OSTEONICS CORP. 510(k) NO: K992570(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 01-SEP-99 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE HWA TEH INDUSTRIAL SDN. BHD. 510(k) NO: K992730(TRADITIONAL) ATTN: K. KARUNAKARAN PHONE NO : 603 871 7351 LOT 187, SUNGAI DAHAR SE DECISION MADE: 14-SEP-99 BTG BERJUNTAI, SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE HWA TEH INDUSTRIAL SDN. BHD. 510(k) NO: K992810(TRADITIONAL) ATTN: K. KARUNAKARAN PHONE NO : 603 871 7351 LOT 187, SUNGAI DAHAR SE DECISION MADE: 27-SEP-99 BTG BERJUNTAI, SELANGOR, MALAYSIA 510(k) STATEMENT DEVICE: HYDROFERA BACTERISTATIC NASAL DRESSING HYDROFERA, LLC 510(k) NO: K983276(TRADITIONAL) ATTN: HEATHER S BOND PHONE NO : 860-456-0677 322 MAIN ST., SUITE 1101 SE DECISION MADE: 14-SEP-99 WILLIMANTIC, CT 06226 510(k) STATEMENT DEVICE: BOLUS ACCESSORY SET I-FLOW CORP. 510(k) NO: K992072(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 15-SEP-99 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QCT BONE MINERAL ANALYSIS SOFTWARE IMAGE ANALYSIS, INC. 510(k) NO: K992246(TRADITIONAL) ATTN: BEN ARNOLD PHONE NO : 502-384-6400 1380 BURKESVILLE ST. SE DECISION MADE: 03-SEP-99 COLUMBIA, KY 42728 510(k) STATEMENT DEVICE: QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 IMMUNETICS, INC. 510(k) NO: K991062(TRADITIONAL) ATTN: ANDREW E LEVIN PHONE NO : 617-492-5416 63 ROGER ST. SE DECISION MADE: 21-SEP-99 CAMBRIDGE,, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 IMMUNETICS, INC. 510(k) NO: K991063(TRADITIONAL) ATTN: ANDREW E LEVIN PHONE NO : 617-492-5416 63 ROGER ST. SE DECISION MADE: 21-SEP-99 CAMBRIDGE,, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMA-B 25-HYDROXY VITAMIN D RIA IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K991998(TRADITIONAL) ATTN: PAUL PUNTIN PHONE NO : 440 191 5190660 10 DIDCOT WAY SE DECISION MADE: 17-SEP-99 BOLDON BUSINESS PARK 510(k) STATEMENT BOLDON, TYNE & WEAR, UNITED KINGDOM NE35 9PD DEVICE: 3I CERAMIC ABUTMENT SYSTEM IMPLANT INNOVATIONS, INC. 510(k) NO: K991947(TRADITIONAL) ATTN: WILLIAM G CONETY PHONE NO : 561-776-6700 4555 RIVERSIDE DR. SE DECISION MADE: 29-SEP-99 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENIUM MICROKERATOME, MODEL IMD-001 INDUSTRIAL & MEDICAL DESIGN, INC. 510(k) NO: K992687(TRADITIONAL) ATTN: YEVGENIY KUKLIN PHONE NO : 213-250-5484 6230 WILSHIRE BLVD., SUITE 410 SE DECISION MADE: 24-SEP-99 LOS ANGELES, CA 90048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFUSION DYNAMICS POWER INFUSER MODEL M100B INFUSION DYNAMICS, INC. 510(k) NO: K992044(TRADITIONAL) ATTN: THOMAS BECZE PHONE NO : 609-951-9596 116 VILLAGE BOULEVARD, SE DECISION MADE: 08-SEP-99 SUITE 200 510(k) STATEMENT PRINCETON, NJ 08540-5799 DEVICE: CHRISTOUDIAS SLIM TIP ELECTRODE INSERT INNERVISION, INC. 510(k) NO: K992345(TRADITIONAL) ATTN: FRANK M LEWIS PHONE NO : 901-682-0417 6258 SHADY GROVE RD.EAST SE DECISION MADE: 10-SEP-99 MEMPHIS, TN 38120 510(k) STATEMENT DEVICE: ORTHOPANTOMOGRAPH OP100D INSTRUMENTARIUM CORP. 510(k) NO: K992385(TRADITIONAL) ATTN: TOMMI JOKINIEMI PHONE NO : 358-925-8854 300 WEST EDGERTON AVENUE SE DECISION MADE: 28-SEP-99 MILWAUKEE, WI 53207 510(k) STATEMENT DEVICE: OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K992670(TRADITIONAL) ATTN: TRICIA WOOD PHONE NO : 412-854-1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 17-SEP-99 BETHEL PARK, PA 15102 510(k) STATEMENT DEVICE: ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 INTELERADIOLOGY, INC. 510(k) NO: K992352(TRADITIONAL) ATTN: MICHAEL VINCENT KLEIN PHONE NO : 626-457-1789 2400 LORAIN ROAD SE DECISION MADE: 29-SEP-99 SAN MARINO, CA 91108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 INTERNATIONAL ISOTOPES, INC. 510(k) NO: K992963(SPECIAL) ATTN: REBECCA ELLIS PHONE NO : 940-484-9492 3100 JIM CHRISTAL RD. SE DECISION MADE: 21-SEP-99 DENTON, TX 76207-2600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT II INTRATHERAPEUTICS, INC. 510(k) NO: K990592(TRADITIONAL) ATTN: CATHY YOHNK PHONE NO : 612-697-2003 651 CAMPUS DR. SE DECISION MADE: 01-SEP-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAMAX ITI GUIDE CATHETER INTRATHERAPEUTICS, INC. 510(k) NO: K992622(SPECIAL) ATTN: AMY PETERSON PHONE NO : 612-697-2076 651 CAMPUS DR. SE DECISION MADE: 29-SEP-99 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MED IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991419(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 14-SEP-99 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TM-300 TRACTION SYSTEM ITO CO., LTD. 510(k) NO: K992545(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 01-SEP-99 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: BIO-97 JENERIC/PENTRON, INC. 510(k) NO: K991901(TRADITIONAL) ATTN: MURRAY G GAMBERG PHONE NO : 800-243-3100 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 07-SEP-99 WALLINGFORD, CT 06492-0724 510(k) STATEMENT DEVICE: THERMALIGHT 2000 JENNIFERMAXX, INC. 510(k) NO: K992630(TRADITIONAL) ATTN: NORMAN ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 10-SEP-99 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 JOSTRA USA 510(k) NO: K992559(TRADITIONAL) ATTN: KATHY JOHNSON PHONE NO : 888-567-8721 2035 SUNSET LAKE RD SE DECISION MADE: 20-SEP-99 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULT KAMIYA BIOMEDICAL CO. 510(k) NO: K992311(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 13-SEP-99 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MUL KAMIYA BIOMEDICAL CO. 510(k) NO: K992312(TRADITIONAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 13-SEP-99 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULAT KARL STORZ ENDOSCOPY 510(k) NO: K992027(TRADITIONAL) ATTN: KEVIN A KENNAN PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 09-SEP-99 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 KAY SEE DENTAL MFG. CO. 510(k) NO: K992609(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 EAST MISSOURI AVE. SE DECISION MADE: 22-SEP-99 KANSAS CITY, MO 64106-1294 510(k) STATEMENT DEVICE: KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURI KENDALL CO. 510(k) NO: K990500(ABBREVIATED) ATTN: PAUL W EVANS PHONE NO : 508-261-8203 15 HAMPSHIRE STREET SE DECISION MADE: 28-SEP-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENON LIGHT SOURCE PES 1 LASER OPTIK SYSTEME GMBH & CO. KG 510(k) NO: K992540(TRADITIONAL) ATTN: R. HAPPERSBERGER PHONE NO : 061 205 533 AM SAGEWERK 11,6500 MAINZ 23 SE DECISION MADE: 14-SEP-99 AMTSGERICHT MAINZ HRB 4527 510(k) STATEMENT GERMANY, GERMANY DEVICE: QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES LATEXX PARTNERS BHD. 510(k) NO: K992671(TRADITIONAL) ATTN: CHONG ENG PHONE NO : 605 891 5555 PT. 5054, SE DECISION MADE: 24-SEP-99 KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA TAIPING, PERAK, MALAYSIA 34600 DEVICE: ROTORBLADE SUTURE ANCHOR LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K992938(SPECIAL) ATTN: RHODEMANN LI PHONE NO : 203-944-2800 4 ARMSTRONG RD. SE DECISION MADE: 23-SEP-99 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "THE LIBERATOR" LIBERATOR WHEELCHAIRS, INC. 510(k) NO: K984391(ABBREVIATED) ATTN: BONNIE BROMLEY PHONE NO : 817-263-5005 7525 PARKWOOD LANE SE DECISION MADE: 03-SEP-99 FT. WORTH, TX 76133 510(k) STATEMENT DEVICE: EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EM LIFETEK MEDICAL, INC. 510(k) NO: K992307(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 14-SEP-99 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 LIFETEK MEDICAL, INC. 510(k) NO: K992308(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 13-SEP-99 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOBUTTON LINVATEC CORP. 510(k) NO: K990194(TRADITIONAL) ATTN: CAROL A WEIDEMAN PHONE NO : 727-399-5334 11311 CONCEPT BLVD. SE DECISION MADE: 17-SEP-99 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORAD 1-650 (INTERNATIONAL 650) LORAD CORP. 510(k) NO: K992280(TRADITIONAL) ATTN: KELVIN BURROUGHS PHONE NO : 203-743-3370 36 APPLE RIDGE RD. SE DECISION MADE: 03-SEP-99 DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GO GLUCOSE MONITORING SYSTEM LXN CORP. 510(k) NO: K991754(TRADITIONAL) ATTN: NEDA RASHTI PHONE NO : 619-546-7500 6325 LUSK BLVD. SE DECISION MADE: 08-SEP-99 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: MEDI-TEST COMBI 11 MACHEREY-NAGEL-DUREN 510(k) NO: K991927(TRADITIONAL) ATTN: EDUARDO MARCH PHONE NO : 301-986-4440 7475 WISCONSIN ANE SE DECISION MADE: 17-SEP-99 SUITE 850 510(k) SUMMARY AVAILABLE FROM FDA BETHESDA, MD 20814 DEVICE: ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING MAERSK MEDICAL, LTD. 510(k) NO: K990810(TRADITIONAL) ATTN: EVAN DICK PHONE NO : 314-721-0112 7527 WESTMORELAND AVENUE SE DECISION MADE: 17-SEP-99 ST. LOUIS, MO 63105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEPPING KINEMATIC IMAGING PLATFORM (SKIP) MAGNETIC MOMENTS, LLC 510(k) NO: K992892(TRADITIONAL) ATTN: ANIL N SHETTY PHONE NO : 248-551-1006 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 16-SEP-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIC TONE ACRYLIC RESINS MANUFACTURERA DENTAL CONTINENTAL 510(k) NO: K991577(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-363-2953 30001 GOLDEN HARTERN #334 SE DECISION MADE: 22-SEP-99 HAGUNA NYVEL, CA 92677 510(k) STATEMENT DEVICE: CONTROL III ELITE MARIL PRODUCTS, INC. 510(k) NO: K992661(TRADITIONAL) ATTN: ANNE R WHITEHAIR PHONE NO : 714-544-7711 320 WEST 6TH ST. SE DECISION MADE: 14-SEP-99 TUSTIN, CA 92780 510(k) STATEMENT DEVICE: CERADIUM NON-PRECIOUS CERAMIC ALLOY MATECH, INC. 510(k) NO: K992705(TRADITIONAL) ATTN: PAUL L SAXTON PHONE NO : 818-367-2472 13010 SAN FERNANDO RD. SE DECISION MADE: 22-SEP-99 SYLMAR, CA 91342 510(k) STATEMENT DEVICE: MODUS SYSTEM SELF-DRILLING SCREWS MEDARTIS AG 510(k) NO: K992106(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 1601 TRAPELO ROAD SE DECISION MADE: 17-SEP-99 RESERVOIR PLACE 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02451 DEVICE: MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 MEDI-STIM A/S 510(k) NO: K992305(TRADITIONAL) ATTN: JON H HOEM PHONE NO : 472 305 9660 PO BOX 35 GREFSEN,N-0409 OSLO SE DECISION MADE: 08-SEP-99 SANDAKERVEIEN 110 510(k) SUMMARY AVAILABLE FROM FDA OSLO, NORWAY N-0475 DEVICE: ARTHROSCOPE / MEDIFIX INC. MEDIFIX INC. 510(k) NO: K992474(TRADITIONAL) ATTN: GEORGE ALBUSECU PHONE NO : 847-965-1898 8727 NARRAGANSETT SE DECISION MADE: 23-SEP-99 MORTON GROVE, IL 60053-0000 510(k) STATEMENT DEVICE: MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES MEDIFIX INC. 510(k) NO: K992480(TRADITIONAL) ATTN: GEORGE ALBULESCU PHONE NO : 847-965-1898 8727 NARRAGANSETT SE DECISION MADE: 23-SEP-99 MORTON GROVE, IL 60053-0000 510(k) STATEMENT DEVICE: SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. 510(k) NO: K992761(TRADITIONAL) ATTN: MOON T KWON PHONE NO : 925-463-1830 6616 OWENS DR. SE DECISION MADE: 01-SEP-99 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM MEDSYS, INC. 510(k) NO: K983717(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 16-SEP-99 HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MADTRONIC DLP ARTERIAL CANNULAE MEDTRONIC, INC. 510(k) NO: K991066(TRADITIONAL) ATTN: JAMES BALUN PHONE NO : 616-242-5283 620 WATSON,SW SE DECISION MADE: 14-SEP-99 P.O.BOX 409 510(k) SUMMARY AVAILABLE FROM FDA GRAND RAPIDS, MI 49501 DEVICE: MEDTRONIC GT2 FUSION GUIDE WIRES MEDTRONIC, INC. 510(k) NO: K992237(SPECIAL) ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DRIVE SE DECISION MADE: 09-SEP-99 DANVERS, MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER MEDTRONIC, INC. 510(k) NO: K992910(SPECIAL) ATTN: DEBRA KRIDNER PHONE NO : 714-779-3650 4633 EAST LA PALMA AVENUE SE DECISION MADE: 15-SEP-99 ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-HBT HELICOBACTER BLOOD TEST METABOLIC SOLUTIONS, INC. 510(k) NO: K990931(TRADITIONAL) ATTN: DAVID A WAGNER PHONE NO : 603-598-6960 460 AMHERST ST. SE DECISION MADE: 24-SEP-99 NASHUA, NH 03063-1220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRX QT. HCG METRIKA, INC. 510(k) NO: K991532(TRADITIONAL) ATTN: YA-CHEN HSU PHONE NO : 408-524-2255 510 OAKMEAD PARKWAY SE DECISION MADE: 17-SEP-99 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATI MICROWAVE MEDICAL SYSTEMS, INC. 510(k) NO: K974387(TRADITIONAL) ATTN: RICHARD S GRABOWY PHONE NO : 978-266-9900 310-312 SCHOOL STREET SE DECISION MADE: 01-SEP-99 ACTON, MA 01720 510(k) STATEMENT DEVICE: MINI-LOGGER SERIES 2000 MINI-MITTER CO., INC. 510(k) NO: K991045(TRADITIONAL) ATTN: JACK E MCKENZIE PHONE NO : 800-685-2999 PO BOX 3386 SE DECISION MADE: 21-SEP-99 56885 ENTERPRISE DR. 510(k) SUMMARY AVAILABLE FROM FDA SUNRIVER, OR 97707 DEVICE: SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 MINIMED TECHNOLOGIES, INC. 510(k) NO: K991979(TRADITIONAL) ATTN: DON SELVEY PHONE NO : 818-362-5958 12744 SAN FERNANDO RD. SE DECISION MADE: 03-SEP-99 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS MINUMYS SURGICAL, INC. 510(k) NO: K992640(TRADITIONAL) ATTN: NOEL MESSENGER PHONE NO : 650-529-2850 10231 BUBB RD. SE DECISION MADE: 08-SEP-99 CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK MINI QUICKANCHOR PLUS MITEK PRODUCTS 510(k) NO: K992487(TRADITIONAL) ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 781-461-9700 60 GLACIER DR. SE DECISION MADE: 21-SEP-99 WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK ROTATOR CUFF QUICKANCHOR PLUS MITEK PRODUCTS 510(k) NO: K992611(TRADITIONAL) ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 781-461-9700 60 GLACIER DR. SE DECISION MADE: 22-SEP-99 WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS 510(k) NO: K992876(SPECIAL) ATTN: PAULA E BULGER PHONE NO : 781-251-2700 60 GLACIER DR. SE DECISION MADE: 24-SEP-99 WESTWOOD, MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVCORE SYSTEM MODULAR CUTTING SYSTEMS INC. 510(k) NO: K990816(TRADITIONAL) ATTN: ALLEN P SCHLEIN PHONE NO : 203-335-1844 650 CLINTON AVE. SE DECISION MADE: 24-SEP-99 BRIDGEPORT, CT 06605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAPURE DP40 CARTRIDGE MRLB INTL., INC. 510(k) NO: K992868(SPECIAL) ATTN: B.J. HAMMARBACK PHONE NO : 218-739-2222 2450 COLLEGE WAY SE DECISION MADE: 07-SEP-99 FERGUS FALLS, MN 56537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE MRLB INTL., INC. 510(k) NO: K992893(SPECIAL) ATTN: B.J. HAMMARBACK PHONE NO : 800-972-3543 2450 COLLEGE WAY SE DECISION MADE: 08-SEP-99 FERGUS FALLS, MN 56537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I MYOTRONICS-NOROMED, INC. 510(k) NO: K992694(SPECIAL) ATTN: FRAY ADIB PHONE NO : 206-243-4214 15425 53RD AVE. SOUTH SE DECISION MADE: 10-SEP-99 TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E100M VENTILATOR (E100M) NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K972833(TRADITIONAL) ATTN: KARON MORELL PHONE NO : 714-642-3910 760 WEST 16TH ST., BLDG. M SE DECISION MADE: 23-SEP-99 COSTA MESA, CA 92627 510(k) STATEMENT DEVICE: MICROKERATOME, MODEL MK-2000 NIDEK, INC. 510(k) NO: K990900(TRADITIONAL) ATTN: JERRY TSUTSUMI PHONE NO : 510-226-5700 47651 WESTINGHOUSE DR. SE DECISION MADE: 24-SEP-99 FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURIN NIHON KOHDEN, INC. 510(k) NO: K991899(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 01-SEP-99 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCE NMT NEUROSCIENCES IMPLANTS S.A. 510(k) NO: K990660(TRADITIONAL) ATTN: BARBARA RAMSEYER PHONE NO : 305-666-0081 6011 CELLINI STREET SE DECISION MADE: 23-SEP-99 CORAL GABLES, FL 33146 510(k) STATEMENT DEVICE: THE NOMOS CHANE II NOMOS CORP. 510(k) NO: K991966(TRADITIONAL) ATTN: WILLIAM O CHISHKO PHONE NO : 724-934-8200 2591 WEXFORD BAYNE RD., #400 SE DECISION MADE: 03-SEP-99 SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERANA NORDISKA DENTAL AB 510(k) NO: K992161(TRADITIONAL) ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA SE DECISION MADE: 22-SEP-99 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAND CERAM NORITAKE CO., INC. 510(k) NO: K992023(TRADITIONAL) ATTN: MARSHA C WERTZBERGER PHONE NO : 202-857-6122 1050 CONNECTICUT AVENUE, N.W. SE DECISION MADE: 03-SEP-99 WASHINGTON, DC 20036-5339 510(k) STATEMENT DEVICE: CO2 GAS WARMER II, MODEL 6-800-00 NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K992381(SPECIAL) ATTN: CASEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 17-SEP-99 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOM INFUSION SYSTEM NOVACON CORP. 510(k) NO: K992015(TRADITIONAL) ATTN: DAVID P LANG PHONE NO : 612-704-9160 5451 HILLTOP AVENUE NORTH SE DECISION MADE: 10-SEP-99 LAKE ELMO, MN 55042-9539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NTERO RF SLEEVE NTERO SURGICAL, INC. 510(k) NO: K992572(TRADITIONAL) ATTN: D. BOMMI BOMMANNAN PHONE NO : 650-428-1000 1137D SAN ANTONIO ROAD SE DECISION MADE: 24-SEP-99 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-48 OLYMPUS AMERICA, INC. 510(k) NO: K984358(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 17-SEP-99 MELVILLE, NY 11042-1179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS WORKING ELEMENT FOR PROBES OLYMPUS WINTER & IBE GMBH 510(k) NO: K992141(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 29-SEP-99 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORATEC BIPOLAR ABLATION PROBES ORATEC INTERVENTIONS, INC. 510(k) NO: K991218(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904 3700 HAVEN CT. SE DECISION MADE: 13-SEP-99 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERI ORFIT INDUSTRIES 510(k) NO: K991319(TRADITIONAL) ATTN: CYNTHIA NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 21-SEP-99 NORTH ATTLEBORO, MA 02760 510(k) STATEMENT DEVICE: NUCLISENS CMV PP67 ORGANON TEKNIKA CORP. 510(k) NO: K983762(TRADITIONAL) ATTN: RON SANYAL PHONE NO : 919-620-2373 100 AKZO AVE. SE DECISION MADE: 15-SEP-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACTALERT FA ORGANON TEKNIKA CORP. 510(k) NO: K992400(TRADITIONAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 03-SEP-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT PF ORGANON TEKNIKA CORP. 510(k) NO: K992401(TRADITIONAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 03-SEP-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT FN ORGANON TEKNIKA CORP. 510(k) NO: K992432(TRADITIONAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 24-SEP-99 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCHEK URINE COLLECTION KIT OSBORN GROUP, INC. 510(k) NO: K991800(TRADITIONAL) ATTN: GILBERT P BOURK III PHONE NO : 913-390-7146 14901 WEST 117TH STREET SE DECISION MADE: 24-SEP-99 OLATHE, KS 66062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WI PACIFIC ANDROLOGY, INC. 510(k) NO: K991381(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 24-SEP-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICR PACIFIC ANDROLOGY, INC. 510(k) NO: K991388(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 13-SEP-99 IRVINE, CA 92606 510(k) STATEMENT DEVICE: PACIFIC HEMOSTASIS THROMBOSCREEN 400C PACIFIC HEMOSTASIS 510(k) NO: K992130(TRADITIONAL) ATTN: LAURA A WORFOLK PHONE NO : 800-528-0494 11515 VANSTORY DR. SE DECISION MADE: 03-SEP-99 HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION G PAMITEX INDUSTRIES SDN BHD 510(k) NO: K991969(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 BATU 2 1/2, JALAN RASAH SE DECISION MADE: 09-SEP-99 SEREMBAN, N.S., MALAYSIA 70300 510(k) STATEMENT DEVICE: PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992117(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 27-SEP-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOV PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992364(TRADITIONAL) ATTN: SAID AWANG PHONE NO : 606 631 3122 2 1/2 MILES, JALAN RASAH SE DECISION MADE: 22-SEP-99 SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT DARUL KHUSUS, MALAYSIA 70300 DEVICE: PASCO MIC AND MIC/ID PANELS (OFLOXACIN) PASCO LABORATORIES, INC. 510(k) NO: K992077(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9594 12750 WEST 42ND AVE. SE DECISION MADE: 03-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS (CEFEPIME) PASCO LABORATORIES, INC. 510(k) NO: K992108(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 03-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) PASCO LABORATORIES, INC. 510(k) NO: K992143(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 16-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, VANCOMYCIN PASCO LABORATORIES, INC. 510(k) NO: K992296(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 800-321-9813 12750 WEST 42ND AVE. SE DECISION MADE: 21-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN PASCO LABORATORIES, INC. 510(k) NO: K992297(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 03-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K992420(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9503 12750 WEST 42ND AVE. SE DECISION MADE: 27-SEP-99 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATTON SPECULUM PATTON MEDICAL CORPORATION 510(k) NO: K991963(TRADITIONAL) ATTN: MICHAEL T PATTON PHONE NO : 512-329-0469 1000 WESTBANK DRIVE SE DECISION MADE: 01-SEP-99 SUITE 5A200 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78746 DEVICE: PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) PERIMED, INC. 510(k) NO: K990960(TRADITIONAL) ATTN: JAMES HOWARD PHONE NO : 301-206-2214 14900 SWEITZER LANE SE DECISION MADE: 23-SEP-99 LAUREL, MD 20707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORAL SLEEP DISORDER AID PERL-RAD SLEEP DISORDER LAB 510(k) NO: K991209(TRADITIONAL) ATTN: ARTHUR PERLIS PHONE NO : 831-626-1222 5315 CARMEL VALLEY RD. A-208 SE DECISION MADE: 22-SEP-99 CARMEL, CA 93923-9558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISINE FOR CONTACTS PFIZER, INC. 510(k) NO: K991620(TRADITIONAL) ATTN: JOHN TOMASZEWSKI PHONE NO : 212-733-6295 235 EAST 42ND ST. SE DECISION MADE: 24-SEP-99 NEW YORK, NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHAZX VLD-100 PHAZX SYSTEMS, INC. 510(k) NO: K992129(TRADITIONAL) ATTN: LEWIS W WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 17-SEP-99 BOULDER, CO 80301 510(k) STATEMENT DEVICE: PHILIPS EASYVISION WORKSTATION: PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K990335(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVENUE SE DECISION MADE: 09-SEP-99 P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484-0917 DEVICE: PHOTON RADIOSURGERY SYSTEM (PRS) PHOTOELECTRON CORP. 510(k) NO: K992577(TRADITIONAL) ATTN: PAUL A PELLETIER PHONE NO : 781-861-2069 5 FORBES RD. SE DECISION MADE: 23-SEP-99 LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILL PHYSIO-CONTROL CORP. 510(k) NO: K990338(TRADITIONAL) ATTN: BOB ZITO PHONE NO : 206-867-4444 11811 WILLOWS RD N.E., P.O. SE DECISION MADE: 01-SEP-99 BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: LIFEPAK 12 BIPHASIC PHYSIO-CONTROL CORP. 510(k) NO: K991910(TRADITIONAL) ATTN: MICHAEL D WILLINGHAM PHONE NO : 425-867-4000 11811 WILLOWS ROAD N.E. SE DECISION MADE: 03-SEP-99 P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073-9706 DEVICE: ENDOSTEPPER 1 PHYTRON- ELEKTRONIK GMBH 510(k) NO: K993188(TRADITIONAL) ATTN: CORNELIUS RIESS PHONE NO : INDUSTRIESTRASSE 12 SE DECISION MADE: 28-SEP-99 D-82194 510(k) SUMMARY AVAILABLE FROM FDA GROBENZELL, GERMANY DEVICE: QUANTITATIVE FLOW PICKER INTERNATIONAL, INC. 510(k) NO: K992225(TRADITIONAL) ATTN: ELAINE K KEELER PHONE NO : 440-473-5591 595 MINER RD. SE DECISION MADE: 07-SEP-99 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PE-PLUS ACETABULAR CUP PLUS ORTHOPEDICS 510(k) NO: K992153(TRADITIONAL) ATTN: HATMUT LOCH PHONE NO : 619-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 23-SEP-99 BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121-1194 DEVICE: RENDER-PLAN 3-D PRECISION THERAPY INTL., INC. 510(k) NO: K992864(SPECIAL) ATTN: PAUL SUMMER PHONE NO : 770-300-9725 3155 NORTHWOODS PKWY. N.W. SE DECISION MADE: 09-SEP-99 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA HL PREMIER LASER SYSTEMS 510(k) NO: K992374(TRADITIONAL) ATTN: BETH A ROBERTS PHONE NO : 317-585-8160 #3 MORGAN SE DECISION MADE: 22-SEP-99 IRVINE, CA 92618 510(k) STATEMENT DEVICE: OPTIMAX/ COMPACT 2 PROTEC MEDIZINTECCHNIK GMBH & CO. 510(k) NO: K992818(TRADITIONAL) ATTN: PHONE NO : 71720 OBERSTENFELD SE DECISION MADE: 01-SEP-99 , GERMANY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKVUE INFLUENZA A/B TEST QUIDEL CORP. 510(k) NO: K991633(TRADITIONAL) ATTN: MARY DE ARMOND PHONE NO : 619-552-7910 10165 MCKELLAR CT. SE DECISION MADE: 24-SEP-99 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIONICS MICROELECTRODE KIT RADIONICS, INC. 510(k) NO: K991399(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 21-SEP-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIONICS XDC EXTERNAL VENTRICULAR CATHETER RADIONICS, INC. 510(k) NO: K992379(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 08-SEP-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE RADIONICS, INC. 510(k) NO: K992721(SPECIAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 10-SEP-99 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K992526(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 24-SEP-99 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 RITA MEDICAL SYSTEMS 510(k) NO: K992693(SPECIAL) ATTN: ERIN DIGNAN PHONE NO : 650-390-8500 967 NORTH SHORELINE BLVD. SE DECISION MADE: 10-SEP-99 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K992558(TRADITIONAL) ATTN: C.M. CHONG PHONE NO : 603 636 8077 LOT 21909, NO.5, LORONG HELAN SE DECISION MADE: 27-SEP-99 HINDIK KEPONG BARU INDUST. EST 510(k) STATEMENT KEPONG BARU, KUALA LUMPUR, MALAYSIA 52100 DEVICE: CARDIOPHONICS 1000 MEMORY MONITOR RLT MEDICAL ASSOC., INC. 510(k) NO: K992772(SPECIAL) ATTN: RICHARD L TRADER PHONE NO : 410-560-6148 9620 DEERECO RD. SE DECISION MADE: 17-SEP-99 TIMONIUM, MD 21093 510(k) STATEMENT DEVICE: INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC ROCHE DIAGNOSTICS CORP. 510(k) NO: K990992(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 30-SEP-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PARATHYROID HORMONE TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K992680(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-845-3723 9115 HAGUE RD. SE DECISION MADE: 28-SEP-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS ESTRADIOL CALSET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K992981(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 24-SEP-99 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F S.S. WHITE TECHNOLOGIES, INC. 510(k) NO: K984415(TRADITIONAL) ATTN: DAVE TAYLOR PHONE NO : 732-752-8300 151 OLD NEW BRUNSWICK ROAD SE DECISION MADE: 29-SEP-99 PISCATAWAY, NJ 08854-3761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES SAFESKIN CORP. 510(k) NO: K992210(TRADITIONAL) ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010 12671 HIGH BLUFF DR. SE DECISION MADE: 10-SEP-99 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAGE CONTRAST MANAGEMENT SYSTEM SAGE LABORATORIES, INC. 510(k) NO: K991112(TRADITIONAL) ATTN: DAVID CHEN PHONE NO : 318-635-1594 5408 INTERSTATE DRIVE SE DECISION MADE: 02-SEP-99 SHREVEPORT, LA 71109 510(k) STATEMENT DEVICE: SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER SALTER LABORATORIES 510(k) NO: K992986(SPECIAL) ATTN: DUANE KAZAL PHONE NO : 805-854-3166 100 WEST SYCAMORE RD. SE DECISION MADE: 24-SEP-99 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMSUNG RAYPAX FILM DIGITIZER SAMSUNG SDS CO., LTD 510(k) NO: K992112(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 09-SEP-99 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMSUNG RAYPAX LONG TERM ARCHIVE SAMSUNG SDS CO., LTD 510(k) NO: K992131(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 13-SEP-99 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMSUNG RAYPAX DISPLAY WORKSTATION SAMSUNG SDS CO., LTD 510(k) NO: K992306(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 22-SEP-99 AUBREY, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K991125(TRADITIONAL) ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828 203 N. WABASH AVENUE SE DECISION MADE: 14-SEP-99 SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60601 DEVICE: EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP SELFCARE, INC. 510(k) NO: K991480(TRADITIONAL) ATTN: CAROL ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 17-SEP-99 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR SHEEN MORE ENT. CO., LTD. 510(k) NO: K992686(TRADITIONAL) ATTN: KEN HUANG PHONE NO : 011 886 55575937 NO.16, TOU KUNG SIX RD. SE DECISION MADE: 24-SEP-99 TOU-LIU EXPANDED INDUST. AREA 510(k) STATEMENT TOU-LIU, YUN-LIN, CHINA (TAIWAN) DEVICE: ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROT SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K992417(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 13-SEP-99 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K992418(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 13-SEP-99 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION SHIELD GLOVES MANUFACTURER (M) SDN510(k) NO: K992419(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 13-SEP-99 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG DILLY PLASTICS PRODUC510(k) NO: K992464(TRADITIONAL) ATTN: XINGLAI ZHOU PHONE NO : 011 863 113830158 NO. 16 ZHI NONG RD. SE DECISION MADE: 14-SEP-99 SHIJIAZHUANG, CHINA 050051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K992860(TRADITIONAL) ATTN: GUI-XI LIU PHONE NO : 863 113 613127 NO. 135 XIN-HUA WEST ROAD SE DECISION MADE: 24-SEP-99 HIJIAZHUANG CITY 510(k) STATEMENT HEBEI PROVINCE, CHINA 050081 DEVICE: SHINMED MODEL SW-966 ULTRASONIC NEBULIZER SHINING WORLD HALTHCARE CO., LTD. 510(k) NO: K980024(TRADITIONAL) ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 03-SEP-99 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KION ANESTHESIA SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K973971(TRADITIONAL) ATTN: DAVID SIMARD PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 13-SEP-99 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL IMAGING SYSTEM (BSR) SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K991922(TRADITIONAL) ATTN: ROBERT W CALLAHAN PHONE NO : 847-304-7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 01-SEP-99 HOFFMAN ESTATES, IL 60195-5203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AX WORKSTATION SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K992073(TRADITIONAL) ATTN: ROBERT W CALLAHAN PHONE NO : 847-304-7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 09-SEP-99 HOFFMAN ESTATES, IL 60195-5203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684 SIGMA DIAGNOSTICS, INC. 510(k) NO: K992798(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 28-SEP-99 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 6 SIGMA DIAGNOSTICS, INC. 510(k) NO: K992800(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 28-SEP-99 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DI SIGMA DIAGNOSTICS, INC. 510(k) NO: K992801(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 28-SEP-99 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 4 SIGMA DIAGNOSTICS, INC. 510(k) NO: K992803(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 13-SEP-99 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 SIMS PORTEX, INC. 510(k) NO: K992057(TRADITIONAL) ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812 10 BOWMAN DR. SE DECISION MADE: 13-SEP-99 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENNIUM GOLD SKYTRON, DIV. THE KMW GROUP, INC. 510(k) NO: K992090(TRADITIONAL) ATTN: KARI OGREEN PHONE NO : 616-957-0500 5000 36TH ST., S.E. SE DECISION MADE: 08-SEP-99 GRAND RAPIDS, MI 49512 510(k) STATEMENT DEVICE: DR. B'S MOUTHPIECE, MODEL 32129-10002 SNORE - EZZER 510(k) NO: K991948(TRADITIONAL) ATTN: ROBERT A GALL PHONE NO : 414-521-2500 1217 SO. GRANDVIEW BLVD. SE DECISION MADE: 02-SEP-99 WAUKESHA, WI 53188 510(k) STATEMENT DEVICE: PREMIER ANTERIOR CERVICAL PLATE SYSTEM SOFAMOR DANEK USA 510(k) NO: K992110(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 14-SEP-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANEK PLATE AND SCREW SYSTEM SOFAMOR DANEK USA,INC. 510(k) NO: K991036(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-346-4124 1800 PYRAMID PLACE SE DECISION MADE: 14-SEP-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM SOFAMOR DANEK USA,INC. 510(k) NO: K992928(SPECIAL) ATTN: BAILEY LIPSCOMB PHONE NO : 1800 PYRAMID PLACE SE DECISION MADE: 21-SEP-99 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SORING GMBH, SONOCA 300 SORING GMBH MEDIZINTECHNIK 510(k) NO: K992026(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 513-786-7458 3200 DOGWOOD COURT SE DECISION MADE: 23-SEP-99 CINCINNATI, OH 45140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPRING POWERLITE 2000 SPRING HEALTH PRODUCTS, INC. 510(k) NO: K992728(TRADITIONAL) ATTN: NATHANIEL H LIEB PHONE NO : 610-630-9171 705 GENERAL WASHINGTON AVE. SE DECISION MADE: 29-SEP-99 #701 510(k) STATEMENT NORRISTOWN, PA 19403 DEVICE: STECO-TITANMAGNETICS STECO-SYSTEM-TECHNIK GMBH & COKG 510(k) NO: K990979(TRADITIONAL) ATTN: JORN PROBST PHONE NO : 499 312 017355 PLEICHERWALL 2 SE DECISION MADE: 03-SEP-99 WURZBURG, BAVARIA, GERMANY 97070 510(k) STATEMENT DEVICE: MIRACLEBREATH TONGUE CLEANER STELLAR LABS, INC. 510(k) NO: K992270(TRADITIONAL) ATTN: HARLAN POMEROY III PHONE NO : 941-926-7745 6637 SUPERIOR AVENUE, SUITE D SE DECISION MADE: 23-SEP-99 SARASOTA, FL 34231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505 STERILEX CORP. 510(k) NO: K991946(TRADITIONAL) ATTN: SHIRA KRAMER PHONE NO : 410-581-8860 7-I GWYNNS MILL COURT SE DECISION MADE: 03-SEP-99 OWINGS MILLS, MD 21117 510(k) STATEMENT DEVICE: PRISMATHERM II, ASTOLINE STIHLER ELECTRONIC GMBH 510(k) NO: K991159(ABBREVIATED) ATTN: RICHARD C LANZILLOTTO PHONE NO : 516-744-0059 30 NORTHPORT ROAD SE DECISION MADE: 03-SEP-99 SOUND BEACH, NY 11789-1734 510(k) STATEMENT DEVICE: ASTOTHERM PLUS, ASTOTUBES, ASTOLINE STIHLER ELECTRONIC GMBH 510(k) NO: K991160(ABBREVIATED) ATTN: RICHARD C LANZILLOTTO PHONE NO : 516-744-0059 30 NORTHPORT ROAD SE DECISION MADE: 02-SEP-99 SOUND BEACH, NY 11789-1734 510(k) STATEMENT DEVICE: BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT STRYKER LEIBINGER 510(k) NO: K991398(TRADITIONAL) ATTN: KRISTYN R KELLEY PHONE NO : 800-253-7370 4100 EAST MILHAM AVE SE DECISION MADE: 22-SEP-99 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO-ESOPHAGEAL MR COIL SURGI-VISION, INC. 510(k) NO: K992193(TRADITIONAL) ATTN: NANCY TAYLOR PHONE NO : 410-730-8998 9250 RUMNSEY ROAD SE DECISION MADE: 03-SEP-99 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA COLUMBIA, MD 21045 DEVICE: SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) SYNTHES (USA) 510(k) NO: K992348(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 P.O. BOX 1766, 1690 RUSSELL SE DECISION MADE: 23-SEP-99 ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: DRUGCHECK X MULTIDRUG SCREENING DEVICE SYNTRON BIORESEARCH, INC. 510(k) NO: K992748(TRADITIONAL) ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223 1420 LOS ANGELES AVE. SE DECISION MADE: 02-SEP-99 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SIMI VALLEY, CA 93065 DEVICE: QUICKPAC II ONE STEP COCAINE TEST SYNTRON BIORESEARCH, INC. 510(k) NO: K992990(TRADITIONAL) ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223 1420 LOS ANGELES AVE. SE DECISION MADE: 20-SEP-99 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA SIMI VALLEY, CA 93065 DEVICE: QUALATEX POWDERED LATEX EXAMINATION GLOVES TAN SIN LIAN INDUSTRIES SDN. BHD. 510(k) NO: K992557(TRADITIONAL) ATTN: TAN TIOW GIN PHONE NO : 006 069 510526 NO. 8, TAMAN MARIN SE DECISION MADE: 14-SEP-99 JALAN HAJI ABDULLAH 510(k) STATEMENT MUAR, JOHOR, MALAYSIA 84000 DEVICE: HELICA "TC" TENERCO, INC. 510(k) NO: K972267(TRADITIONAL) ATTN: JOHN B WEBB PHONE NO : 714-673-6531 1020 W BAY AVE. SE DECISION MADE: 14-SEP-99 NEWPORT BEACH, CA 92661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX SX10 HARDSHELL RESEVOIR TERUMO MEDICAL CORP. 510(k) NO: K991973(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 410-398-8500 125 BLUE BALL RD. SE DECISION MADE: 03-SEP-99 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO U-100 INSULIN SYRINGE TERUMO MEDICAL CORP. 510(k) NO: K992802(SPECIAL) ATTN: KRISTINE WAGNER PHONE NO : 410-392-7241 125 BLUE BALL RD. SE DECISION MADE: 09-SEP-99 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL HAEMOLYTIC COMPLEMENT RID KIT THE BINDING SITE, LTD. 510(k) NO: K992488(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 EAST TOWER, SUITE 600 SE DECISION MADE: 17-SEP-99 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 THE KENDALL CO. LP 510(k) NO: K992079(SPECIAL) ATTN: PAUL W EVANS PHONE NO : 508-261-8203 15 HAMPSHIRE ST. SE DECISION MADE: 29-SEP-99 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAC PRN NEEDLELESS ACCESS CONNECTOR THE KIPP GROUP 510(k) NO: K992268(TRADITIONAL) ATTN: TIM L TRUITT PHONE NO : 909-390-9080 930 WANAMAKER AVE. SE DECISION MADE: 15-SEP-99 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: AEROCHAMBER PLUS VALVED HOLDING CHAMBER TRUDELL MEDICAL INT'L 510(k) NO: K992917(SPECIAL) ATTN: DARRYL FISCHER PHONE NO : 519 455 7060 725 THIRD STREET SE DECISION MADE: 14-SEP-99 LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT DEVICE: PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) TZ MEDICAL, INC. 510(k) NO: K983196(TRADITIONAL) ATTN: BYRON ZAHLER PHONE NO : 503-639-0262 15858 S.W. UPPER BOONES FERRY SE DECISION MADE: 15-SEP-99 RD. 510(k) STATEMENT LAKE OSWEGO, OR 97035 DEVICE: PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT TZ MEDICAL, INC. 510(k) NO: K983232(TRADITIONAL) ATTN: BYRON G ZAHLER PHONE NO : 503-639-0282 15858 S.W. UPPER BOONES FERRY SE DECISION MADE: 15-SEP-99 RD. 510(k) STATEMENT LAKE OSWEGO, OR 97035 DEVICE: EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER ULTRAWIN SDN BHD 510(k) NO: K992175(TRADITIONAL) ATTN: MELANIE LIM PHONE NO : 605 201 3888 LOT 2, PESIARAN PERINDUSTRIAN SE DECISION MADE: 24-SEP-99 KANTHAN 2 510(k) STATEMENT CHEMOR, PERAK, MALAYSIA 31200 DEVICE: TENS/FES/NMES ELECTRODES UNI-PATCH, INC. 510(k) NO: K983097(TRADITIONAL) ATTN: MANAGER J GEOLAT PHONE NO : 651-565-2601 P.O. BOX 271 SE DECISION MADE: 17-SEP-99 1313 WEST GRANT BLVD. 510(k) SUMMARY AVAILABLE FROM FDA WABASHA, MN 55981-0271 DEVICE: CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM VARIAN ASSOC., INC. 510(k) NO: K992753(SPECIAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3045 HANOVER STREET SE DECISION MADE: 03-SEP-99 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O2N DEMAND-II, VICTOR MODEL OCPR-II VICTOR EQUIPMENT CO. 510(k) NO: K992659(SPECIAL) ATTN: DICK LANGFORD PHONE NO : 940-381-1374 2800 AIRPORT RD. SE DECISION MADE: 03-SEP-99 DENTON, TX 76207 510(k) STATEMENT DEVICE: CUFF-ABLE PLUS VITAL SIGNS, INC. 510(k) NO: K990412(TRADITIONAL) ATTN: ANTHONY P MARTINO PHONE NO : 973-790-1330 20 CAMPUS RD. SE DECISION MADE: 01-SEP-99 TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSTIC ULTRASOUND, MODEL 1.0 VOLUMETRICS MEDICAL IMAGING INC. 510(k) NO: K992378(TRADITIONAL) ATTN: JIM MUNDELL PHONE NO : 919-682-6400 700 MAIN ST. SE DECISION MADE: 29-SEP-99 DURHAM, NC 27701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC 510(k) NO: K991683(TRADITIONAL) ATTN: TIMOTHY J RYNN PHONE NO : 800-437-8181 3250 WEST KITTLE LANE SE DECISION MADE: 08-SEP-99 P.O. BOX 300 510(k) SUMMARY AVAILABLE FROM FDA FLAGSTAFF,, AZ 86002-0300 DEVICE: WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM WALLACH SURGICAL DEVICES, INC. 510(k) NO: K992736(TRADITIONAL) ATTN: MICHAEL MALIS PHONE NO : 203-799-2000 235 EDISON RD. SE DECISION MADE: 29-SEP-99 ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENON XENON LIGHT SOURCE WALTER LORENZ SURGICAL, INC. 510(k) NO: K992050(TRADITIONAL) ATTN: TREVOR BYRD PHONE NO : 904-741-4400 1520 TRADEPORT DRIVE SE DECISION MADE: 14-SEP-99 JACKSONVILLE, FL 32218-2480 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LORENZ EXTERNAL MANDIBULAR DISTRACTOR WALTER LORENZ SURGICAL, INC. 510(k) NO: K992873(SPECIAL) ATTN: DIANA PRESTON PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 17-SEP-99 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE HEATING TUBING SET #7642HSES WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K990662(TRADITIONAL) ATTN: S. GRUNWALD PHONE NO : 490 810 489080 RUDOLF-DIESEL-RING 20 SE DECISION MADE: 24-SEP-99 SAUERLACH, GERMANY D-82054 510(k) STATEMENT DEVICE: MODULAR RADIAL HEAD WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K991915(TRADITIONAL) ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-4620 5677 AIRLINE RD. SE DECISION MADE: 03-SEP-99 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-QUEST WUESTEC MEDICAL, INC. 510(k) NO: K992103(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 800-638-9729 5600 COMMERCE BLVD., EAST SE DECISION MADE: 01-SEP-99 MOBILE, AL 36619 510(k) STATEMENT DEVICE: MICRO-FRANCE LIPOSUCTION CANNULAS XOMED, INC. 510(k) NO: K992282(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-296-0980 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 23-SEP-99 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 ZCV ,INC. 510(k) NO: K990689(TRADITIONAL) ATTN: PRISCILLA WHITEHEAD COX PHONE NO : 732-225-3800 298 FERNWOOD AVE. SE DECISION MADE: 03-SEP-99 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K991180(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 906-526-3744 200 EVANS WAY SE DECISION MADE: 03-SEP-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K991185(TRADITIONAL) ATTN: MARK KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 03-SEP-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST ZEUS SCIENTIFIC, INC. 510(k) NO: K992166(TRADITIONAL) ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 03-SEP-99 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHA ZOLL MEDICAL CORP. 510(k) NO: K990762(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 800-242-9150 32 SECOND AVE. SE DECISION MADE: 03-SEP-99 BURLINGTON, MA 01803 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 318 TOTAL WITH SUMMARIES 228 TOTAL WITH STATEMENTS 90
Updated 10/21/1999
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