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510(k)s Final Decisions Rendered for August 2000 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-AUG-2000 THROUGH 31-AUG-2000 DEVICE: ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP AB BIODISK 510(k) NO: K001547(TRADITIONAL) ATTN: ANNE BOLMSTROM PHONE NO : 46 873 00760 DALVAGEN 10 SE DECISION MADE: 07-AUG-00 SOLNA, SWEDEN S-169 56 510(k) STATEMENT DEVICE: LIFESHIELD ADDITIVE PIERCING PIN ABBOTT LABORATORIES 510(k) NO: K002006(TRADITIONAL) ATTN: THOMAS P SAMPOGNA PHONE NO : 847-935-3715 DEPT. 389, AP30 SE DECISION MADE: 10-AUG-00 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-3537 DEVICE: CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) ADVANCED STERILIZATION PRODUCTS 510(k) NO: K002401(SPECIAL) ATTN: NEELU MEDHEKER PHONE NO : 949-789-3838 33 TECHNOLOGY DR. SE DECISION MADE: 29-AUG-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERONEB II, MODEL APN 200 AEROGEN INC. 510(k) NO: K992831(TRADITIONAL) ATTN: TRACI V. A EDWARDS PHONE NO : 408-543-2414 1310 ORLEANS DR. SE DECISION MADE: 25-AUG-00 SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HP M2376A DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. 510(k) NO: K002009(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD., MS 0491 SE DECISION MADE: 02-AUG-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER AGILENT TECHNOLOGIES, INC. 510(k) NO: K002397(TRADITIONAL) ATTN: PAUL SMOLENSKI PHONE NO : 978-659-3380 3000 MINUTEMAN RD. SE DECISION MADE: 17-AUG-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DA VINCHI EMG/EP ISA1004EP AIRSEP CORP. 510(k) NO: K001467(TRADITIONAL) ATTN: PETER WEISENBORN PHONE NO : 716-691-0202 290 CREEKSIDE DR. SE DECISION MADE: 01-AUG-00 BUFFALO, NY 14228-2070 510(k) STATEMENT DEVICE: IMPULSE SELECT AIRSEP CORP. 510(k) NO: K001579(TRADITIONAL) ATTN: JAMES A ALESSI PHONE NO : 716-691-0202 290 CREEKSIDE DR. SE DECISION MADE: 31-AUG-00 BUFFALO, NY 14228-2070 510(k) STATEMENT DEVICE: ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K993524(TRADITIONAL) ATTN: RENEE L FLUET PHONE NO : 619-458-7563 10221 WATERIDGE CIRCLE SE DECISION MADE: 01-AUG-00 SAN DIEGO, CA 92121-2733 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST ALATEX SCIENTIFIC, INC. 510(k) NO: K001126(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-691-4770 2440 LEGHORN STREET SE DECISION MADE: 07-AUG-00 MOUNTIAN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994395(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 07-AUG-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994399(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 04-AUG-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994400(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 04-AUG-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994403(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 14-AUG-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994406(TRADITIONAL) ATTN: NAISHU WANG PHONE NO : 858-350-9798 11494 SORRENTO VALLEY RD., SE DECISION MADE: 14-AUG-00 SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: SURGICAL DRAPES ALLEGIANCE HEALTHCARE COPORATION 510(k) NO: K002419(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKERGAN ROAD SE DECISION MADE: 15-AUG-00 BUILDING WM 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: ALLEGIANCE GENESIS CONTAINER SYSTEM ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K983299(TRADITIONAL) ATTN: PATRICIA SHARPE-GREGG PHONE NO : 847-578-3636 1500 WAUKEGAN RD. SE DECISION MADE: 04-AUG-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX MODULAR HIP STEM APEX SURGICAL, LLC 510(k) NO: K000788(TRADITIONAL) ATTN: EDWARD J CHEAL PHONE NO : 508-884-9611 39 TAUNTON GREEN, SUITE 202 SE DECISION MADE: 04-AUG-00 TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIDESCAN APPLIED IMAGING CORP. 510(k) NO: K001420(TRADITIONAL) ATTN: DIANE OATES PHONE NO : 408-562-0250 2380 WALSH AVENUE, BUILDING B SE DECISION MADE: 30-AUG-00 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX CHONDRAL DART, MODEL AR-4005B-18 ARTHREX, INC. 510(k) NO: K991971(TRADITIONAL) ATTN: VERNON C BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 04-AUG-00 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE CORP. 510(k) NO: K001588(TRADITIONAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 17-AUG-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODE ASAHI MEDICAL CO., LTD. 510(k) NO: K001250(TRADITIONAL) ATTN: DAVID L WEST PHONE NO : 301-272-3113 1801 ROCKVILLE PIKE PIKE SE DECISION MADE: 16-AUG-00 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: DC-TELL AUSTENAL, INC. 510(k) NO: K001799(TRADITIONAL) ATTN: RONALD DUDEK PHONE NO : 773-735-0600 4101 WEST 51ST ST. SE DECISION MADE: 10-AUG-00 CHICAGO, IL 60632-4287 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC ZIRKON AUSTENAL, INC. 510(k) NO: K001815(TRADITIONAL) ATTN: RONALD DUDEK PHONE NO : 773-735-0600 4101 WEST 51ST ST. SE DECISION MADE: 10-AUG-00 CHICAGO, IL 60632-4287 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVID-NIT LOSS OF RESISTANCE SYRINGE AVID MEDICAL, INC. 510(k) NO: K001731(TRADITIONAL) ATTN: SEAN F SHEMANSKI PHONE NO : 757-566-3510 9000 WESTMONT DR. SE DECISION MADE: 29-AUG-00 STONEHOUSE COMMERCE PARK 510(k) STATEMENT TOANO, VA 23168 DEVICE: DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 AXIS-SHIELD LTD. 510(k) NO: K001981(TRADITIONAL) ATTN: EILEEN MCCAFFERTY PHONE NO : 440 138 2422000 THE TECHNOLOGY PARK SE DECISION MADE: 21-AUG-00 DUNDEE, TAYSIDE, SCOTLAND, UNITED 510(k) STATEMENT DEVICE: MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (B AXYA MEDICAL, INC. 510(k) NO: K002435(SPECIAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 24-AUG-00 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: ULTRASOUND SCANNER, TYPE 1101 B & K MEDICAL A/S 510(k) NO: K002085(SPECIAL) ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100 SANDTOFTEN 9 SE DECISION MADE: 01-AUG-00 GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUMER FEMORAL HEAD BAUMER S.A. 510(k) NO: K001571(TRADITIONAL) ATTN: BRENO C FARAGO, JR. PHONE NO : 551 938 8063030 AV. PREF. ANTONIO TAVARES SE DECISION MADE: 04-AUG-00 LEITE NR: 181 510(k) STATEMENT MOGI MIRIM, SAN PAULO, BRAZIL 13800-000 DEVICE: ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY A BECKMAN COULTER, INC. 510(k) NO: K001935(TRADITIONAL) ATTN: ANGELA M BYLAND PHONE NO : 612-368-1615 1000 LAKE HAZELTINE DR. SE DECISION MADE: 22-AUG-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SY BECKMAN COULTER, INC. 510(k) NO: K002453(SPECIAL) ATTN: JAN OLSEN PHONE NO : 612-368-1269 1000 LAKE HAZELTINE DRIVE SE DECISION MADE: 31-AUG-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLEEVA FOAM BIO MED SCIENCES, INC. 510(k) NO: K002109(TRADITIONAL) ATTN: MARK E DILLON PHONE NO : 610-432-8220 1111 HAMILTON STREET SE DECISION MADE: 31-AUG-00 ALLENTOWN, PA 18101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 BIO-RAD LABORATORIES 510(k) NO: K002120(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 21-AUG-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 BIO-RAD LABORATORIES 510(k) NO: K002196(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 07-AUG-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 BIO-RAD LABORATORIES 510(k) NO: K002460(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 31-AUG-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, BIO-RAD LABORATORIES 510(k) NO: K002535(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 30-AUG-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 6 BIO-RAD LABORATORIES 510(k) NO: K002536(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 30-AUG-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULAN -CALCIUM SULFATE BONE VOID FILTER BIOCOMPOSITES LTD. 510(k) NO: K001724(TRADITIONAL) ATTN: STEPHEN BRATT PHONE NO : 440 178 2206500 ETRUSCAN STREET SE DECISION MADE: 04-AUG-00 ETRURIA 510(k) SUMMARY AVAILABLE FROM FDA STOKE ON TRENT, STAFFORDSHIRE, UNITED KINGDOM ST1 5PQ DEVICE: BIOLOK SCREW BIOCOMPOSITES LTD. 510(k) NO: K002070(TRADITIONAL) ATTN: J.STEPHEN BRATT PHONE NO : 441 782 206500 ETRUSCAN ST., ETRURIA SE DECISION MADE: 25-AUG-00 STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB MENISCAL SCREW BIOMET MANUFACTURING, INC. 510(k) NO: K002020(TRADITIONAL) ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 25-AUG-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: GROSS FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K001580(TRADITIONAL) ATTN: TINA LAKIN PHONE NO : 219-267-6639 56 EAST BELL DRIVE SE DECISION MADE: 17-AUG-00 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: RADIOLUCENT COLLES FRACTURE KIT BIOMET, INC. 510(k) NO: K001760(ABBREVIATED) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 56 EAST BELL SE DECISION MADE: 31-AUG-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46582 DEVICE: M2A 28MM RINGLOC LINER BIOMET, INC. 510(k) NO: K002379(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 56 EAST BELL DRIVE SE DECISION MADE: 31-AUG-00 WARSAW, IN 46582-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB PANELS AND FASTENERS BIOMET, INC. 510(k) NO: K984390(TRADITIONAL) ATTN: TRACY J BICKEL PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 07-AUG-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MO BIOSENSE WEBSTER, INC. 510(k) NO: K002333(SPECIAL) ATTN: MARIA D OCHOA PHONE NO : 909-839-8593 3333 DIAMOND CANYON RD. SE DECISION MADE: 31-AUG-00 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALEO HYDRO AND GALEO HYDRO J-TIP BIOTRONIK, INC. 510(k) NO: K001736(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 02-AUG-00 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHIN BLEASE MEDICAL EQUIPMENT LTD. 510(k) NO: K001727(SPECIAL) ATTN: ART WARD PHONE NO : 813-645-2855 962 ALLEGRO LANE SE DECISION MADE: 09-AUG-00 APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BMT ANSCORE HEALTH MANAGEMENT SYSTEM BOSTON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K993875(TRADITIONAL) ATTN: CESIDIO TEMPESTA PHONE NO : 781-213-9200 591 NORTH AVE., SUITE 5 SE DECISION MADE: 11-AUG-00 WAKEFIELD, MA 01880-1641 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAZELLE BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K001134(TRADITIONAL) ATTN: JENNIFER BOLTON PHONE NO : 508-650-8000 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 31-AUG-00 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K001338(TRADITIONAL) ATTN: ABBY LIPMAN PHONE NO : 508-650-8249 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 30-AUG-00 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GDC ULTRASOFT COIL BOSTON SCIENTIFIC, TARGET 510(k) NO: K002181(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 11-AUG-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELSIOR 1018 MICROCATHETER BOSTON SCIENTIFIC, TARGET 510(k) NO: K994155(TRADITIONAL) ATTN: ROXANNE K BAXTER PHONE NO : 510-624-2105 47900 BAYSIDE PARKWAY SE DECISION MADE: 03-AUG-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMA SMARTBELT, MODEL 0560 BRAEBON MEDICAL CORP. 510(k) NO: K001743(SPECIAL) ATTN: RICHARD A BONATO PHONE NO : 613 831 6690 120 WALGREEN DRIVE SE DECISION MADE: 25-AUG-00 SUITE #1 510(k) STATEMENT RR#3 CARP, ONTARIO, CANADA KOA 1LO DEVICE: PAIN CARE 2000L BREG, INC. 510(k) NO: K002321(SPECIAL) ATTN: KATHLEEN BARBER PHONE NO : 760-599-3000 2611 COMMERCE WAY SE DECISION MADE: 14-AUG-00 VISTA, CA 92083 510(k) STATEMENT DEVICE: FLUOROTEX II SURGICAL MESH BRIDGER BIOMED, INC. 510(k) NO: K002351(TRADITIONAL) ATTN: BRUCE G RUEFER PHONE NO : 406-586-7666 2430 NORTH 7TH AVE., SUITE 4 SE DECISION MADE: 26-AUG-00 BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARONY BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K002205(ABBREVIATED) ATTN: RICHARD KELLER PHONE NO : 800-882-8183 1780 EXECUTIVE DR. SE DECISION MADE: 10-AUG-00 OCONOMOWOC, WI 53066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTRACE, MODEL 1730 BRYAN CORP. 510(k) NO: K002063(TRADITIONAL) ATTN: ROSE S LOGSDON PHONE NO : 781-935-0004 FOUR PLYMPTON ST. SE DECISION MADE: 10-AUG-00 WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELERATOR RECIPROCATING CANNULA BYRON MEDICAL 510(k) NO: K001803(TRADITIONAL) ATTN: REGINA S HARRIS PHONE NO : 520-573-0857 602 W RILLITO ST. SE DECISION MADE: 04-AUG-00 TUCSON, AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 CAMBRIDGE HEART, INC. 510(k) NO: K002230(SPECIAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 18-AUG-00 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA DYNAMIC COOLING DEVICE CANDELA CORP. 510(k) NO: K001589(TRADITIONAL) ATTN: JOAN M CLIFFORD PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 18-AUG-00 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESIDE HEMOGLOBIN CARESIDE HEMOTOLOGY, INC. 510(k) NO: K001462(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 21-AUG-00 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 CASCO-NERL DIAGNOSTICS CORPORATION510(k) NO: K002174(TRADITIONAL) ATTN: KAREN HICKEY PHONE NO : 207-878-7550 500 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 22-AUG-00 PORTLAND, ME 04103 510(k) STATEMENT DEVICE: CERAMIX PORCELAIN SYSTEM CERAMIX CORPORATION 510(k) NO: K000983(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 26-AUG-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D10 810NM LASER, MODEL CERALAS D10-60 CERAMOPTEC, INC. 510(k) NO: K001975(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 04-AUG-00 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 CHARLES A. SMITH 510(k) NO: K000859(TRADITIONAL) ATTN: CHARLES A SMITH PHONE NO : 502-969-9652 811 STARLITE DR. SE DECISION MADE: 23-AUG-00 LOUISVILLE, KY 40207 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARTER MEDICAL NEONATAL SYRINGE SET CHARTER MEDICAL, LTD. 510(k) NO: K000685(TRADITIONAL) ATTN: K. ALICE PREVILLE PHONE NO : 732-775-0363 1805 SWARTHMORE AVE. SE DECISION MADE: 15-AUG-00 LAKEWOOD, NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. 510(k) NO: K001662(TRADITIONAL) ATTN: DAVE HERNON PHONE NO : 972-783-0644 1710 FIRMAN DRIVE SE DECISION MADE: 02-AUG-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA RICHARDSON, TX 75081 DEVICE: OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE CHINA NANTONG GUANGDA TEXTILE CO.,510(k) NO: K001858(TRADITIONAL) ATTN: YONG ZHANG PHONE NO : 630-240-1570 1532 LONGMEADOW ROAD SE DECISION MADE: 17-AUG-00 BARTLETT, IL 60103 510(k) STATEMENT DEVICE: DIALGUARD ENDOTOXIN REMOVAL DEVICE CLARIGEN, INC. 510(k) NO: K993806(TRADITIONAL) ATTN: EDIT HEGYI PHONE NO : 760-929-4996 5922 FARNSWORTH COURT SE DECISION MADE: 14-AUG-00 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & CLEARWATER COLON HYDROTHERAPY, INC510(k) NO: K000388(TRADITIONAL) ATTN: STUART K BAKER PHONE NO : 727-726-7782 4451-A S. PINE AVE. SE DECISION MADE: 08-AUG-00 OCALA, FL 34480 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K992905(TRADITIONAL) ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404 325 PARAMOUNT DRIVE SE DECISION MADE: 01-AUG-00 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED B COL-BAR LTD. 510(k) NO: K001598(TRADITIONAL) ATTN: JOHNATHAN S KAHAN PHONE NO : 202-637-5794 555 13TH STREET, N.W. SE DECISION MADE: 22-AUG-00 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MIC COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K002065(TRADITIONAL) ATTN: CHEE Y FOO PHONE NO : 605 847 2777 LOT 821, JALAN MATANG SE DECISION MADE: 22-AUG-00 TAIPING, PERAK DARUL RIDZUAN, MALA510(k) STATEMENT DEVICE: WATER FOR TISSUE CULTURE, MODELS 1500 CONCEPTION TECHNOLOGIES 510(k) NO: K993140(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 02-AUG-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: D. R. MEDICAL CONTROLLED PRESSURE GARMENTS CONFECTION MEDICALE D.R. INC. 510(k) NO: K001300(TRADITIONAL) ATTN: GUY HOUDE PHONE NO : 514 252 5553 4220, DE ROUEN ST. #200 SE DECISION MADE: 30-AUG-00 MONTREAL, QC, CANADA HIV 3T2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREFIT DISPERSIVE ELECTRODE CONMED CORP. 510(k) NO: K002002(TRADITIONAL) ATTN: IRA D DUESLER, JR. PHONE NO : 315-797-8375 310 BROAD ST. SE DECISION MADE: 17-AUG-00 UTICA, NY 13501-1203 510(k) STATEMENT DEVICE: SPECTRUM SILICONE FOLEY CATHETER COOK UROLOGICAL, INC. 510(k) NO: K000251(TRADITIONAL) ATTN: BRENDA DAVIS PHONE NO : 812-829-4891 1100 WEST MORGAN STREET SE DECISION MADE: 30-AUG-00 P.O. BOX 271 510(k) SUMMARY AVAILABLE FROM FDA SPENCER, IN 47460 DEVICE: ATHOS COSMOS MEDICAL TECHNOLOGY 510(k) NO: K001704(TRADITIONAL) ATTN: JOHN CLARK PHONE NO : 909-587-6306 42230 ZEVO DR. SE DECISION MADE: 31-AUG-00 TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) CP MEDICAL 510(k) NO: K002190(TRADITIONAL) ATTN: PATRICK FERGUSON PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 10-AUG-00 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 CREATIVE PLASTIC TECHNOLOGY 510(k) NO: K001106(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 949-240-1290 24312 ARMADA DR. SE DECISION MADE: 16-AUG-00 DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFIER CROSSTAT 510(k) NO: K001878(TRADITIONAL) ATTN: M. JOSEPH OLK PHONE NO : 314-781-9664 8045 BIG BEND BLVD., SUITE 203 SE DECISION MADE: 03-AUG-00 WEBSTER GROVES, MO 63119-2714 510(k) STATEMENT DEVICE: EHC500 DESKTOP PATIENT STATION, MODEL EHC500 CYBERCARE, INC. 510(k) NO: K002388(SPECIAL) ATTN: J. TERRY DRURY PHONE NO : 770-352-9540 7840 ROSWELL RD., SUITE 320 SE DECISION MADE: 25-AUG-00 ATLANTA, GA 30350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 DADE BEHRING, INC. 510(k) NO: K001645(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-392-5639 7739 NW 48 STREET SE DECISION MADE: 04-AUG-00 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33166 DEVICE: DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET DATASCOPE CORP. 510(k) NO: K002365(SPECIAL) ATTN: JOANN WOLF PHONE NO : 973-244-6100 15 LAW DR. SE DECISION MADE: 25-AUG-00 FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION DATEX-OHMEDA 510(k) NO: K001814(ABBREVIATED) ATTN: JOEL KENT PHONE NO : 978-640-0460 THREE HIGHWOOD DRIVE SE DECISION MADE: 23-AUG-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER 1 DENTAL ALLOY PRODUCTS, INC. 510(k) NO: K002298(TRADITIONAL) ATTN: RODNEY GUYTON PHONE NO : 310-637-9711 1190 MAHALO PLACE SE DECISION MADE: 24-AUG-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: E-Z LINK CROSS CONNECTOR DEPUY ACROMED 510(k) NO: K001470(TRADITIONAL) ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DR. SE DECISION MADE: 04-AUG-00 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTIMA METAL-ON-METAL ACETABULAR CUP DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001523(TRADITIONAL) ATTN: CHERYL HASTINGS PHONE NO : 219-371-4901 P.O. BOX 988 SE DECISION MADE: 10-AUG-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITAN POROCOAT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001991(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 25-AUG-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY NEUFLEX PIP FINGER DEPUY, INC. 510(k) NO: K001922(TRADITIONAL) ATTN: JANET G JOHNSON PHONE NO : 219-371-4907 700 ORTHOPAEDIC DR. SE DECISION MADE: 29-AUG-00 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: EXPLORER CVS TRANSCRANIAL DOPPLER DIAGNOSTIC MEDICAL SYSTEMS 510(k) NO: K990517(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 PO BOX 12038 SE DECISION MADE: 01-AUG-00 LA JOLLA, CA 92039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K001767(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 07-AUG-00 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K001875(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 21-AUG-00 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAFLOW DMG USA, INC. 510(k) NO: K002086(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 17-AUG-00 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRACHYSEED DRAXIMAGE INC. 510(k) NO: K000475(TRADITIONAL) ATTN: R.J. FLANAGAN PHONE NO : 514 630 7039 16751 TRANS CANADA HIGHWAY SE DECISION MADE: 22-AUG-00 KIRKLAND, QC, CANADA H9H4J4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIN-1 TANGO DURACARE MEDICAL EQUIPMENT, L.C. 510(k) NO: K000204(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 01-AUG-00 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEI SLUSH PAN DRAPE EAGLE ENDOSCOPIC, INC. 510(k) NO: K001994(TRADITIONAL) ATTN: JOHN MAYALL PHONE NO : 940-464-6021 700 SEALS RD. SE DECISION MADE: 04-AUG-00 BARTONVILLE, TX 76226 510(k) STATEMENT DEVICE: STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAF EDWARDS LIFESCIENCES, LLC 510(k) NO: K001565(TRADITIONAL) ATTN: JOHN W SMITH PHONE NO : 801-565-6213 6864 SOUTH 300 WEST SE DECISION MADE: 10-AUG-00 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTERIOR CERVICAL PLATE SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K001847(TRADITIONAL) ATTN: JOANNA MONAHON PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 24-AUG-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIC SPO2 FINGER SENSOR, MODEL E412-20 EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K002223(SPECIAL) ATTN: KRISTA OAKES PHONE NO : 972-801-9854 1800 10TH ST., SUITE 300 SE DECISION MADE: 22-AUG-00 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEMP H ESPE DENTAL AG 510(k) NO: K002364(SPECIAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 10-AUG-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, EXACTECH, INC. 510(k) NO: K002141(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 16-AUG-00 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 EXCEL TECH. LTD. 510(k) NO: K000919(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 31-AUG-00 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A.V. FISTULA NEEDLE EXELINT INTERNATIONAL COMPANY 510(k) NO: K001496(TRADITIONAL) ATTN: ARMAND HAMID PHONE NO : 310-649-0707 5840 W. CENTINELA AVENUE SE DECISION MADE: 01-AUG-00 LOS ANGELES, CA 90045 510(k) STATEMENT DEVICE: FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN FERRIS MFG. CORP. 510(k) NO: K002129(TRADITIONAL) ATTN: THEODORE THORSEN PHONE NO : 630-734-7830 16 W. 300 83RD ST. SE DECISION MADE: 25-AUG-00 BURR RIDGE, IL 60521 510(k) STATEMENT DEVICE: MICROTARGETING ELECTRODE FHC, INC. 510(k) NO: K991522(TRADITIONAL) ATTN: FREDERICK HAER PHONE NO : 207-666-8190 9 MAIN STREET SE DECISION MADE: 04-AUG-00 BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 FISMA, INC. 510(k) NO: K000158(TRADITIONAL) ATTN: DOUGLAS A KANE PHONE NO : 801-972-0500 3959 WEST 1820 SOUTH SE DECISION MADE: 24-AUG-00 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING FLEXSITE DIAGNOSTICS, INC. 510(k) NO: K001810(TRADITIONAL) ATTN: DONALD R STONE PHONE NO : 202-496-7620 1900 K STREET, N.W. SE DECISION MADE: 14-AUG-00 WASHINGTON, DC 20006-1108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR FLUID PROCESS SYSTEMS, INC. 510(k) NO: K991495(TRADITIONAL) ATTN: STEPHEN C HAMBRIC PHONE NO : 915-852-1007 998-A PEYTON RD. SE DECISION MADE: 28-AUG-00 EL PASO, TX 79927 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS OPTIFLUX 200NR FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K002277(SPECIAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVENUE SE DECISION MADE: 25-AUG-00 LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINKMAX GC AMERICA, INC. 510(k) NO: K001823(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 708-597-0900 3737 WEST 127TH STREET SE DECISION MADE: 16-AUG-00 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE MARQUETTE ECG ANALYSIS PROGRAM GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K002209(SPECIAL) ATTN: KRISTIN PABST PHONE NO : 414-371-3736 8200 WEST TOWER AVE. SE DECISION MADE: 18-AUG-00 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROVASCULAR ARRAY COIL GE MEDICAL SYSTEMS, INC. 510(k) NO: K001946(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 30-AUG-00 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-BLOCKS GEISTLICH-PHARMA 510(k) NO: K970569(TRADITIONAL) ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378 1050 CONNECTICUT AVE. N.W. SE DECISION MADE: 14-AUG-00 WASHINGTON, DC 20036 510(k) STATEMENT DEVICE: REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 GENDRON, INC. 510(k) NO: K001923(TRADITIONAL) ATTN: FREDERIC W STROBEL PHONE NO : 419-445-6060 400 EAST LUGBILL RD. SE DECISION MADE: 25-AUG-00 P.O. BOX 0197 510(k) SUMMARY AVAILABLE FROM FDA ARCHBOLD, OH 43502-0197 DEVICE: VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW GLORMED INTL., INC. 510(k) NO: K002340(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 22-AUG-00 SPARKS, NV 89434 510(k) STATEMENT DEVICE: LA JOIE GOOMI EHWA, INC. 510(k) NO: K000736(TRADITIONAL) ATTN: MANOH PARK PHONE NO : 408-996-1973 P.O. BOX 2123 SE DECISION MADE: 08-AUG-00 CUPERTINO, CA 95015 510(k) STATEMENT DEVICE: HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI GUIDANT CORP. 510(k) NO: K002206(TRADITIONAL) ATTN: MARGARET ANDERSON PHONE NO : 408-845-3995 3200 LAKESIDE DR. SE DECISION MADE: 24-AUG-00 P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054-2807 DEVICE: OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS GUILIN LATEX FACTORY 510(k) NO: K994118(TRADITIONAL) ATTN: PETER WEI PHONE NO : 415-681-9760 93 MORNINGSIDE DRIVE SE DECISION MADE: 14-AUG-00 SAN FRANCISCO, CA 94132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELI HANDSAFE PRODUCTS SDN. BHD. 510(k) NO: K000913(TRADITIONAL) ATTN: NG KOK HWA PHONE NO : 606 952 9003 LOT 4209 JALAN BAKARIAH SE DECISION MADE: 10-AUG-00 MUAR, JOHOR, MALAYSIA 84000 510(k) STATEMENT DEVICE: CONSENSUS KNEE SYSTEM HAYES MEDICAL, INC. 510(k) NO: K001456(TRADITIONAL) ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 07-AUG-00 EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT DEVICE: KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-100 HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K002221(TRADITIONAL) ATTN: DAGMAR S MASER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 09-AUG-00 AMSTERDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENRAF-NONIUS SONOPULS 190 SYSTEM HENLEY HEALTHCARE, INC. 510(k) NO: K000084(TRADITIONAL) ATTN: REBECCA STOUT PHONE NO : 281-276-7000 120 INDUSTRIAL BLVD. SE DECISION MADE: 04-AUG-00 SUGAR LAND, TX 77478 510(k) STATEMENT DEVICE: PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA HOMEDICS, INC. 510(k) NO: K001860(TRADITIONAL) ATTN: MICHEAL NELSON PHONE NO : 248-863-3000 3000 PONTIAC TRAIL, SE DECISION MADE: 10-AUG-00 COMMERCE TOWNSHIP, MI 48390 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT ACETABULAR SHELLS: PS-HA HOWMEDICA OSTEONICS CORP. 510(k) NO: K001448(TRADITIONAL) ATTN: TERRY S POWELL PHONE NO : 201-934-4375 59 ROUTE 17 SE DECISION MADE: 04-AUG-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIDENT ACETABULAR SHELLS: PS HOWMEDICA OSTEONICS CORP. 510(k) NO: K001449(TRADITIONAL) ATTN: TERRY S POWELL PHONE NO : 201-934-4375 59 ROUTE 17 SE DECISION MADE: 04-AUG-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER TRAUMA PELVIC SET HOWMEDICA OSTEONICS CORP. 510(k) NO: K001614(TRADITIONAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 04-AUG-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY HOWMEDICA OSTEONICS CORP. 510(k) NO: K001653(TRADITIONAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 18-AUG-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUNTER SCIENTIFIC INJECTION PIPETTES HUNTER SCIENTIFIC LIMITED 510(k) NO: K001615(TRADITIONAL) ATTN: MARK RAWE PHONE NO : 440 179 9541688 UNIT 1, PRIORS HALL, SE DECISION MADE: 18-AUG-00 WIDDINGTON 510(k) SUMMARY AVAILABLE FROM FDA SAFFRON WALDEN, ESSEX, UNITED KINGDOM CB113SB DEVICE: BABY DOPPLEX 4000 (BD4000) HUNTLEIGH DIAGNOSTICS LTD. 510(k) NO: K001677(SPECIAL) ATTN: B. J COLLEYPRIEST PHONE NO : 440 292 0485885 35 PORTMANMOOR ROAD SE DECISION MADE: 14-AUG-00 CARDIFF, UNITED KINGDOM CF2 2HB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER HYPERBARIC TECHNOLOGIES INC. 510(k) NO: K001409(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 02-AUG-00 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ IMPLEX CORP. 510(k) NO: K001471(TRADITIONAL) ATTN: JOHN A SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 07-AUG-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ IMPLEX CORP. 510(k) NO: K001759(TRADITIONAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 24-AUG-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINOLTA PULSOX-3/MINOLTA PULSOX-3I IN-X CORP. 510(k) NO: K984570(TRADITIONAL) ATTN: CHARLIE HENRY PHONE NO : 303-238-4935 1610 PIERCE STREET, SUITE 150 SE DECISION MADE: 30-AUG-00 LAKEWOOD, CO 80214-1489 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUE INFINITY EXTRUSION & ENGINEERING, 510(k) NO: K993913(TRADITIONAL) ATTN: DOUGLAS WILKINS PHONE NO : 408-727-6030 3350 SCOTT BLVD., BLDG.6 SE DECISION MADE: 09-AUG-00 UNIT 601 510(k) SUMMARY AVAILABLE FROM FDA SANTA CLARA, CA 95054 DEVICE: DETRUSAN 500 INNOVAMED USA, INC. 510(k) NO: K994109(TRADITIONAL) ATTN: E.H. CZADILEK PHONE NO : 941-850-2744 1140 LEE BLVD., SUITE 101-103 SE DECISION MADE: 03-AUG-00 LEHIGH ACRES, FL 33936 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA INSTRUMENTARIUM IMAGING, INC. 510(k) NO: K001928(TRADITIONAL) ATTN: DOUG WOODS PHONE NO : 414-747-1030 300 WEST EDGERTON AVE. SE DECISION MADE: 02-AUG-00 MILWAUKEE, WI 53207-6025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION OF ACL ADVANCE INSTRUMENTATION LABORATORY CO. 510(k) NO: K002400(SPECIAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 30-AUG-00 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT DOUBLESTRUT PARAMOUNT INTRATHERAPEUTICS, INC. 510(k) NO: K001648(TRADITIONAL) ATTN: CATHY YOHNK PHONE NO : 612-697-2003 651 CAMPUS DR. SE DECISION MADE: 28-AUG-00 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM INTUITIVE SURGICAL, INC. 510(k) NO: K001666(TRADITIONAL) ATTN: DAVID CASAL PHONE NO : 650-237-7013 1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 24-AUG-00 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGER II M6, MODEL IN-888WNL INVACARE CORP. 510(k) NO: K002157(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 25-AUG-00 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 9000 PEDIATRIC WHEELCHAIR INVACARE CORP. 510(k) NO: K002170(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 04-AUG-00 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: INVACARE LIFT CHAIR INVACARE CORP. 510(k) NO: K002171(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 10-AUG-00 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: MODEL 9000 BARIATRIC WHEELCHAIR INVACARE CORP. 510(k) NO: K002317(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 25-AUG-00 P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA ELYRIA, OH 44036-2125 DEVICE: PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 INVITROCARE, INC. 510(k) NO: K001967(TRADITIONAL) ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986 11408 SORRENTO VALLEY RD. SE DECISION MADE: 14-AUG-00 SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: PHORESOR MODEL PM2000 IOMED, INC. 510(k) NO: K001410(TRADITIONAL) ATTN: W. TIM MILLER PHONE NO : 801-975-1191 3385 WEST 1820 SOUTH SE DECISION MADE: 01-AUG-00 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JBC OPAQUE AND GLITTER J.B.C AND COMPANY 510(k) NO: K002048(TRADITIONAL) ATTN: PRISCILLA L MIER PHONE NO : 702-914-8842 6280 SOUTH VALLEY VIEW BLVD., SE DECISION MADE: 30-AUG-00 #122 510(k) SUMMARY AVAILABLE FROM FDA LAS VEGAS, NV 89118 DEVICE: RD-2104 J.F. JELENKO & CO., INC. 510(k) NO: K002222(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600 99 BUSINESS PARK DR. SE DECISION MADE: 31-AUG-00 ARMONK, NY 10504 510(k) STATEMENT DEVICE: WILLI GELLER CREATION & AV PORCELAIN JENSEN INDUSTRIES, INC. 510(k) NO: K002041(TRADITIONAL) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 16-AUG-00 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTAFLOW CENTRIFUGAL PUMP SYSTEM JOSTRA MEDIZINTECHNIK AG 510(k) NO: K991864(TRADITIONAL) ATTN: KATHY JOHNSON PHONE NO : 888-567-8721 2035 SUNSET LAKE RD. SE DECISION MADE: 31-AUG-00 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA MONOPOLAR VAPORIZATION ELECTRODES KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K001740(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 22-AUG-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARMAN WHEELCHAIR KARMAN HEALTHCARE INC. 510(k) NO: K002167(TRADITIONAL) ATTN: ALEX C HORNG PHONE NO : 626-968-2508 137 8TH AVE., #F SE DECISION MADE: 25-AUG-00 LA PUENTE, CA 91746 510(k) STATEMENT DEVICE: KARMAN WHEELCHAIR KARMAN HEALTHCARE INC. 510(k) NO: K002202(TRADITIONAL) ATTN: ALEX C HORNG PHONE NO : 626-968-2508 137 8TH AVE., #F SE DECISION MADE: 25-AUG-00 LA PUENTE, CA 91746 510(k) STATEMENT DEVICE: PERMLASTIC 2 KERR CORP. 510(k) NO: K001655(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 10-AUG-00 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM KONTRON MEDICAL SYSTEMS SAS 510(k) NO: K002239(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 08-AUG-00 HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KONTUR 55 SOFT LENS KONTUR KONTACT LENS CO., INC. 510(k) NO: K001908(TRADITIONAL) ATTN: KEVIN M RANDALL PHONE NO : 303-664-0539 P.O. BOX 253 SE DECISION MADE: 18-AUG-00 LAFAYETTE, CO 80026 510(k) STATEMENT DEVICE: CLEARFIL ST OPAQUER KURARAY COMPANY, LTD. 510(k) NO: K001913(TRADITIONAL) ATTN: KOICHI K IKUCHI PHONE NO : 212-986-2230 200 PARK AVENUE SE DECISION MADE: 04-AUG-00 30TH FI. METLIFE BUILDING 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10166-3098 DEVICE: CLEARFIL REPAIR KURARAY COMPANY, LTD. 510(k) NO: K001914(TRADITIONAL) ATTN: KOICHI KIKUCHI PHONE NO : 212-986-2230 200 PARK AVENUE SE DECISION MADE: 10-AUG-00 30TH FI. METLIFE BUILDING 510(k) SUMMARY AVAILABLE FROM FDA NEW YORK, NY 10166-3098 DEVICE: CAPELLA MADSEN ELECTRONICS 510(k) NO: K002200(TRADITIONAL) ATTN: JIM BERGERSON PHONE NO : 612-930-0416 5600 ROWLAND RD. SE DECISION MADE: 25-AUG-00 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 MAERSK MEDICAL A/S 510(k) NO: K002138(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO ROAD SE DECISION MADE: 29-AUG-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLDFINGER DEVICE MALI-TECH LTD. 510(k) NO: K001162(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 972 0673 POB 454 SE DECISION MADE: 09-AUG-00 GINOT SHOMRON, ISRAEL 44853 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLARD AIR OXYGEN ACCUBLENDER MALLARD MEDICAL, INC. 510(k) NO: K001609(TRADITIONAL) ATTN: ROBERT PEARSON PHONE NO : 530-226-0727 20268 SKYPARK DR. SE DECISION MADE: 10-AUG-00 REDDING, CA 96002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES MAPA PROFESSIONAL 510(k) NO: K994124(TRADITIONAL) ATTN: ALEJANDRO SANCHEZ PHONE NO : 011 528 4170030 CARRETERA SALTILLO-GENERAL SE DECISION MADE: 11-AUG-00 CEPEDA 947 COL. LA ENCANTADA 510(k) SUMMARY AVAILABLE FROM FDA SALTILLO COAH, MEXICO DEVICE: POWERDRIVE 350 OPTION MARCONI MEDICAL SYSTEMS 510(k) NO: K002415(SPECIAL) ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743 595 MINER RD. SE DECISION MADE: 18-AUG-00 HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ML EYE SPEAR, MODEL ML 27 ES MED-LOGICS, INC. 510(k) NO: K002279(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-363-2953 30001 GOLDEN LANTERN #334 SE DECISION MADE: 18-AUG-00 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX MED-TEC,INC. 510(k) NO: K001052(TRADITIONAL) ATTN: DONALD F RIIBE PHONE NO : 712-737-8688 1401 8TH STREET S.E. SE DECISION MADE: 30-AUG-00 P.O. BOX 320 510(k) STATEMENT ORANGE CITY, IA 51041 DEVICE: WIZAIR COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N510(k) NO: K002287(SPECIAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 25-AUG-00 RA'ANANNA 43373, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K002116(SPECIAL) ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 09-AUG-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIMX SYSTEM MEDICAL MANAGER RESEARCH DEVELOPME510(k) NO: K002100(TRADITIONAL) ATTN: JEFFREY K SHAPIRO PHONE NO : 202-637-5775 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 25-AUG-00 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K994283(TRADITIONAL) ATTN: J.I. HOLLANDER PHONE NO : 317 152 23244 POORTGEBOUW RIJNSBURGERWEG 10 SE DECISION MADE: 30-AUG-00 2333 AA LEIDEN 510(k) SUMMARY AVAILABLE FROM FDA , NETHERLANDS DEVICE: SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. 510(k) NO: K002185(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 01-AUG-00 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON CO., LTD. 510(k) NO: K002491(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 25-AUG-00 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE FUGO BLADE MEDISURG RESEARCH AND MANAGEMENT C510(k) NO: K001498(TRADITIONAL) ATTN: RICHARD J FUGO PHONE NO : 610-277-3937 100 WEST FORNANCE STREET SE DECISION MADE: 10-AUG-00 NORRISTOWN, PA 19401 510(k) STATEMENT DEVICE: MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT MEDIVATORS, INC. 510(k) NO: K993042(TRADITIONAL) ATTN: NORMAN MINER PHONE NO : 817-595-1222 7423 AIRPORT FREEWAY SE DECISION MADE: 17-AUG-00 FORT WORTH, TX 76118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMEN MEDNET LOCATOR, INC. 510(k) NO: K001404(TRADITIONAL) ATTN: JUDY CHANDLER PHONE NO : 901-754-2713 7000 SHADOW OAKS SE DECISION MADE: 08-AUG-00 MEMPHIS, TN 38125 510(k) STATEMENT DEVICE: HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACE MEDNET LOCATOR, INC. 510(k) NO: K001406(TRADITIONAL) ATTN: JUDY CHANDLER PHONE NO : 901-754-2713 7000 SHADOW OAKS SE DECISION MADE: 08-AUG-00 MEMPHIS, TN 38125 510(k) STATEMENT DEVICE: GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTL MEDTRONIC, INC. 510(k) NO: K001969(SPECIAL) ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 37A CHERRY HILL DRIVE SE DECISION MADE: 16-AUG-00 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOTRAX MEDWAVE, INC. 510(k) NO: K001898(TRADITIONAL) ATTN: DONNA R LUNAK PHONE NO : 651-639-1227 4382 ROUND LAKE RD. WEST SE DECISION MADE: 31-AUG-00 ARDEN HILLS, MN 55112-3923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIC, MODEL SO-100 METRON MEDICAL AUSTRALIA P/L 510(k) NO: K000593(TRADITIONAL) ATTN: ROB HOPKINS PHONE NO : 613 977 51234 57 ASTER AVE. SE DECISION MADE: 04-AUG-00 CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT DEVICE: MICOR ANESTHESIA CONDUCTION KIT MICOR INC. 510(k) NO: K001940(TRADITIONAL) ATTN: JEREMIAH COSTELLO PHONE NO : 412-487-1113 2855 OXFORD BLVD. SE DECISION MADE: 11-AUG-00 ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 MICRO THERAPEUTICS, INC. 510(k) NO: K002212(SPECIAL) ATTN: MARIBELLE AGUINALDO PHONE NO : 949-837-3700 2 GOODYEAR SE DECISION MADE: 03-AUG-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 MICROLIFE CORP. 510(k) NO: K000969(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 22-AUG-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 MICROLIFE CORP. 510(k) NO: K001182(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 01-AUG-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 MINIMED INC. 510(k) NO: K001827(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO ROAD SE DECISION MADE: 18-AUG-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARADIGM 1.5ML RESERVOIR, MODEL 326 MINIMED INC. 510(k) NO: K001828(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO ROAD SE DECISION MADE: 18-AUG-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIMED PARADIGM INSULIN PUMP, MODEL 511 MINIMED INC. 510(k) NO: K001829(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO ROAD SE DECISION MADE: 18-AUG-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 MINIMED INC. 510(k) NO: K001832(TRADITIONAL) ATTN: JENNIFER LYONS PHONE NO : 818-362-5958 12744 SAN FERNANDO ROAD SE DECISION MADE: 18-AUG-00 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR MINNESOTA MINING AND MFG. CO. 510(k) NO: K000355(TRADITIONAL) ATTN: GRETCHEN KEENAN PHONE NO : 651-733-7605 3M CENTER, BUILDING 275-5W-06 SE DECISION MADE: 23-AUG-00 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM MITEK PRODUCTS 510(k) NO: K002402(SPECIAL) ATTN: MARY P LEGAW PHONE NO : 781-251-3134 249 VANDERBILT AVE. SE DECISION MADE: 31-AUG-00 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM MITEK PRODUCTS 510(k) NO: K002422(SPECIAL) ATTN: MARY P LEGRAW PHONE NO : 781-251-3134 249 VANDERBILT AVE. SE DECISION MADE: 31-AUG-00 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX MOGUL ENTERPRISES 510(k) NO: K993698(ABBREVIATED) ATTN: JAMIL MOGUL PHONE NO : 408-629-3340 6387 SAN IGNACIO AVENUE SE DECISION MADE: 16-AUG-00 SAN JOSE, CA 95119 510(k) STATEMENT DEVICE: HAC-300 HEAD ARRAY COIL MRI DEVICES CORP. 510(k) NO: K001944(TRADITIONAL) ATTN: TOM SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 14-AUG-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: OBC-096 BREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K002539(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 30-AUG-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: NEOCONTROL PELVIC FLOOR THERAPY SYSTEM NEOTONUS, INC. 510(k) NO: K001903(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 29-AUG-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO SCAN MEDICAL SYSTEMS A4000 NEURO SCAN LABS 510(k) NO: K001562(TRADITIONAL) ATTN: DAVID B JONES PHONE NO : 915-845-5600 5700 CROMO DR., SUITE 100 SE DECISION MADE: 16-AUG-00 EL PASO, TX 79912-5538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH II NEW STAR LASERS, INC. 510(k) NO: K002347(SPECIAL) ATTN: DONALD V JOHNSON PHONE NO : 530-823-1434 11802 KEMPER RD. SE DECISION MADE: 17-AUG-00 AUBURN, CA 95603 510(k) STATEMENT DEVICE: NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VEN NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K992133(TRADITIONAL) ATTN: ROBERT W DICK PHONE NO : 949-642-3910 760 WEST 16TH ST., BLDG. N SE DECISION MADE: 04-AUG-00 COSTA MESA, CA 92627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL NEXT MILLENNIUM SOFTWARE SOLUTIONS510(k) NO: K001091(TRADITIONAL) ATTN: JUAN OMAR PEREZ PHONE NO : 305-231-0562 7224 WEST 29TH WAY SE DECISION MADE: 10-AUG-00 HIALEAH, FL 33018 510(k) STATEMENT DEVICE: CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 NIEN MADE ELECTRNICS CORPORATION 510(k) NO: K993950(TRADITIONAL) ATTN: JAMES M DELANEY PHONE NO : 978-371-0066 100 MAIN STREET SE DECISION MADE: 23-AUG-00 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA CONCORD, MA 01742 DEVICE: LIFE SCOPE EC, MODEL BSM-1102 NIHON KOHDEN AMERICA, INC. 510(k) NO: K000517(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 31-AUG-00 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINA SYSTEM NORTH AMERICAN MEDICAL CORPORATION510(k) NO: K002260(TRADITIONAL) ATTN: CARLOS BECERRA PHONE NO : 404-242-4243 6595 ROSWELL RD. STE 811 SE DECISION MADE: 25-AUG-00 ATLANTA, GA 30328 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLO ASSISTANT, MODEL 4-250-00 NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K001325(TRADITIONAL) ATTN: CASEY KUREK PHONE NO : 847-608-8900 600 CHURCH RD. SE DECISION MADE: 18-AUG-00 ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STATLYTE NA/K/CL/LI ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K001761(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT STREET SE DECISION MADE: 07-AUG-00 WALTHAM, MA 02454 510(k) STATEMENT DEVICE: R.TEST EVOLUTION NOVACOR DIV. 510(k) NO: K993788(TRADITIONAL) ATTN: LYNETTE L HOWARD PHONE NO : 908-788-4580 203 MAIN STREET PMB 166 SE DECISION MADE: 04-AUG-00 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMOSTREAK NOVAMED LTD. 510(k) NO: K000718(TRADITIONAL) ATTN: GERALD M SLUTZKY PHONE NO : 972 267 81861 28 PIERRE KOENIG ST., SE DECISION MADE: 24-AUG-00 TALPIOT INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 93469 DEVICE: ODONTOSURGE 3 ODONTO-WAVE 510(k) NO: K001560(TRADITIONAL) ATTN: JAMES DIEROFF PHONE NO : 800-368-5776 1136 EAST STUART #4203 SE DECISION MADE: 24-AUG-00 FORT COLLINS, CO 80525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOTAL PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. 510(k) NO: K002121(TRADITIONAL) ATTN: SHERYL BROWN-SHIMER PHONE NO : 617-492-7289 80 ROGERS ST. SE DECISION MADE: 30-AUG-00 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLEXED PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. 510(k) NO: K002313(TRADITIONAL) ATTN: SHERYL BROWN-SHIMER PHONE NO : 617-441-4410 80 ROGERS ST. SE DECISION MADE: 30-AUG-00 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHONE ONI, INCORPORATED 510(k) NO: K001773(ABBREVIATED) ATTN: MICHAEL A DOUGLAS PHONE NO : 978-683-8881 790 TURNPIKE STREET, STE 100 SE DECISION MADE: 18-AUG-00 NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 ORTHOSOFT, INC. 510(k) NO: K002053(SPECIAL) ATTN: NICOLE LANDREVILLE PHONE NO : 514 861 4074 80 QUEEN ST., SUITE 604 SE DECISION MADE: 03-AUG-00 MONTREAL, QUEBEC, CANADA H3C 2N5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSI SKULL CLAMP PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K002276(TRADITIONAL) ATTN: GARY COOPER PHONE NO : 800-810-6610 360 INDUSTRIAL RD., UNIT H SE DECISION MADE: 29-AUG-00 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARALLAX CRANIOSET PARALLAX MEDICAL, INC. 510(k) NO: K994022(TRADITIONAL) ATTN: SUSAN MARQUES PHONE NO : 650-934-6969 453 RAVENDALE DR., SUITE B SE DECISION MADE: 31-AUG-00 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORAMATRON V, MODEL D680 PARKELL, INC. 510(k) NO: K002195(TRADITIONAL) ATTN: DANIEL R SCHECHTER PHONE NO : 631-249-1134 155 SCHMITT BLVD. SE DECISION MADE: 30-AUG-00 P.O. BOX 376 510(k) STATEMENT FARMINGDALE, NY 11735 DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K001721(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 800-321-9813 12750 WEST 42ND AVE. SE DECISION MADE: 04-AUG-00 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K001887(TRADITIONAL) ATTN: LINDA K DILLION PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 09-AUG-00 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K001953(TRADITIONAL) ATTN: LINDA K DILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 10-AUG-00 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT L PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K002314(TRADITIONAL) ATTN: TAN KONG CHANG PHONE NO : 603 391 1949 LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 17-AUG-00 SELANGOR, MALAYSIA 41720 510(k) STATEMENT DEVICE: RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLO PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K002112(TRADITIONAL) ATTN: PETER YEW NEING CHOON PHONE NO : 606 677 2781 EMPAT, SENAWANG INDUSTRIAL SE DECISION MADE: 14-AUG-00 ESTATE, 70450 SEREMBAN, NEGERI 510(k) SUMMARY AVAILABLE FROM FDA SEMBILAN DARUL KHUSUS MALAYSIA, MALI DEVICE: RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K002114(TRADITIONAL) ATTN: PETER YEW NIENG CHOON PHONE NO : 606 677 2781 EMPAT, SENAWANG INDUSTRIAL SE DECISION MADE: 11-AUG-00 ESTATE, 70450 SEREMBAN, NEGERI 510(k) SUMMARY AVAILABLE FROM FDA SEMBILAN DARUL KHUSUS MALAYSIA, MALI DEVICE: TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 50 PIONEER SURGICAL TECHNOLOGY 510(k) NO: K001709(TRADITIONAL) ATTN: AMY H MOMMAERTS PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 31-AUG-00 MARQUETTE, MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAINSENSE WHEELCHAIR PLAINSENSE WHEELCHAIRS, INC. 510(k) NO: K001909(TRADITIONAL) ATTN: PHONE NO : 2919 BENTWOOD DRIVE SE DECISION MADE: 25-AUG-00 MARIETTA, GA 30062-4608 510(k) STATEMENT DEVICE: RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY 510(k) NO: K001960(TRADITIONAL) ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638 1400 N GOODMAN STREET SE DECISION MADE: 28-AUG-00 ROCHESTER, NY 14692-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 PRECISION THERAPY INTL., INC. 510(k) NO: K002240(SPECIAL) ATTN: PAUL SUMNER PHONE NO : 770-300-9725 3155 NORTHWOODS PKWY. N.W. SE DECISION MADE: 23-AUG-00 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORO HEADREST SYSTEM PRO-MED INSTRUMENTS GMBH 510(k) NO: K001808(TRADITIONAL) ATTN: ANITA THIBEAULT PHONE NO : 678-461-5559 9070 BLUFFVIEW TRACE SE DECISION MADE: 04-AUG-00 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLYCOSAL HBA1C TEST PROVALIS DIAGNOSTICS LTD. 510(k) NO: K001392(TRADITIONAL) ATTN: TOM TSAKERIS PHONE NO : 301-330-2076 16809 BRIARDALE ROAD SE DECISION MADE: 21-AUG-00 ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANSIBAR CPAP SYSTEM PRYM MEDICAL LTD. 510(k) NO: K000888(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 15-AUG-00 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N PULMONOX MEDICAL CORP. 510(k) NO: K000653(TRADITIONAL) ATTN: PAULA TOMAT PHONE NO : 780 662 3968 5243-53 AVE. SE DECISION MADE: 04-AUG-00 TOFIELD, ALBERTA, CANADA T0B 4J0 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURILENS SALINE SOLUTION PURILENS, INC. 510(k) NO: K002319(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 30-AUG-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUINTON Q-STRESS, MODEL 000483 QUINTON INSTRUMENT CO. 510(k) NO: K001492(ABBREVIATED) ATTN: DAVID HIMES PHONE NO : 425-402-2484 3303 MONTE VILLA PKWY. SE DECISION MADE: 09-AUG-00 BOTHELL, WA 98021-8906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KWIKKMODEL R-DENTAL DENTALERZEUGNISSE GMBH 510(k) NO: K001414(TRADITIONAL) ATTN: ANDREAS SPRAFKE PHONE NO : 004 940 22757617 WINTERHUDER WEG 88 SE DECISION MADE: 09-AUG-00 HAMBURG, D-22085, GERMANY D-22085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM RADIONICS, INC. 510(k) NO: K992226(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814 22 TERRY AVE. SE DECISION MADE: 04-AUG-00 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX C-REACTIVE PROTEIN RANDOX LABORATORIES LTD. 510(k) NO: K001009(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 44 028 94422413 ARDMORE, 55 DIAMOND ROAD SE DECISION MADE: 04-AUG-00 CRUMLIN, CO. ANTRIM, UNITED KINGDO510(k) STATEMENT DEVICE: REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, S REMED PHARMA 510(k) NO: K993389(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 18-AUG-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY REMED PHARMA 510(k) NO: K993403(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 18-AUG-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, S REMED PHARMA 510(k) NO: K993409(ABBREVIATED) ATTN: E.J. SMITH PHONE NO : 410-451-0639 PO BOX 4341 SE DECISION MADE: 18-AUG-00 CROFTON, MD 21114 510(k) STATEMENT DEVICE: RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS RICH-MAR CORP. 510(k) NO: K000808(TRADITIONAL) ATTN: DAVID RICHARDS PHONE NO : 918-543-2222 15499 EAST 590TH RD. SE DECISION MADE: 25-AUG-00 P.O. BOX 879 510(k) STATEMENT INOLA, OK 74036 DEVICE: HDL CHOLESTEROL PLUS ROCHE DIAGNOSTICS CORP. 510(k) NO: K000568(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 04-AUG-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS HCG TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K002148(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 22-AUG-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CA 15-3 CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K002353(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 10-AUG-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMPONS ROSTAM LTD. 510(k) NO: K001641(TRADITIONAL) ATTN: ROBERT J STAAB PHONE NO : 201-327-0035 73 FRANKLIN TPK. SE DECISION MADE: 03-AUG-00 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS-4M+MUSCLE STIMULATOR RS MEDICAL 510(k) NO: K000114(TRADITIONAL) ATTN: JOEL S FADEN PHONE NO : 301-881-9139 14401 S.E. FIRST ST. SE DECISION MADE: 10-AUG-00 VANCOUVER, WA 98684 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY SANGUI BIOTECH, INC. 510(k) NO: K001943(TRADITIONAL) ATTN: JOHN J KIANG PHONE NO : 714-429-7807 1508 BROOKHOLLOW DR., #354 SE DECISION MADE: 23-AUG-00 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSE 1 SCANDITRONIX WELLHOFER NORTH AMERI510(k) NO: K000209(TRADITIONAL) ATTN: CHUCK LINDLEY PHONE NO : 901-386-2242 3111 STAGE POST DR., SUITE 105 SE DECISION MADE: 18-AUG-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSA SCANTIBODIES LABORATORY, INC. 510(k) NO: K001411(TRADITIONAL) ATTN: RICHARD LENART PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 21-AUG-00 SANTEE, CA 92071 510(k) STATEMENT DEVICE: IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIM SCIMEDX CORP. 510(k) NO: K002107(TRADITIONAL) ATTN: GARY LEHNUS,PH.D PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 04-AUG-00 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. 510(k) NO: K002134(SPECIAL) ATTN: CAROL A ADILETTO, M.S. PHONE NO : 781-647-3900 200 PROSPECT STREET SE DECISION MADE: 07-AUG-00 WALTHAM, MA 02453 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR SENSIDYNE, INC. 510(k) NO: K000700(TRADITIONAL) ATTN: HOWARD MILLS PHONE NO : 727-530-3602 16333 BAY VISTA DRIVE SE DECISION MADE: 31-AUG-00 CLEARWATER, FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K002216(TRADITIONAL) ATTN: JANNA T TUCKER PHONE NO : 775-342-2612 198 AVE. DE LA D' EMERALD SE DECISION MADE: 11-AUG-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K002217(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVE. DE LA D' EMERALD SE DECISION MADE: 11-AUG-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K002218(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVE. DE LA D' EMERALD SE DECISION MADE: 15-AUG-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K002220(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVE. DE LA D' EMERALD SE DECISION MADE: 15-AUG-00 SPARKS, NV 89434-9550 510(k) STATEMENT DEVICE: LUBRIGEL PERSONAL LUBRICANT SHEFFIELD LABORATORIES, DIV. OF FA510(k) NO: K001077(TRADITIONAL) ATTN: KATHLEEN HACKU PHONE NO : 860-442-4451 170 BROAD ST. SE DECISION MADE: 02-AUG-00 NEW LONDON, CT 06320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K002012(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-262-8860 12390 EAST END AVENUE SE DECISION MADE: 09-AUG-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K002015(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-262-8860 12390 EAST END AVENUE SE DECISION MADE: 09-AUG-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) SIEMENS MEDICAL CORP. 510(k) NO: K994231(TRADITIONAL) ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950 186 WOOD AVE. SOUTH SE DECISION MADE: 10-AUG-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K001400(TRADITIONAL) ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229 22010 S.E. 51ST ST. SE DECISION MADE: 01-AUG-00 ISSAQUAH, WA 98029-7002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OR TABLE/MAGNETOM OPEN VIVA SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K002225(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVENUE SOUTH SE DECISION MADE: 08-AUG-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SI SIENCO, INC. 510(k) NO: K002528(SPECIAL) ATTN: BARBARA DEBIASE PHONE NO : 303-420-1148 11485-A WEST 48TH AVE. SE DECISION MADE: 31-AUG-00 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100 SIGMA DIAGNOSTICS, INC. 510(k) NO: K001403(TRADITIONAL) ATTN: WILLIAM R GILBERT PHONE NO : 314-286-6693 545 SOUTH EWING AVE. SE DECISION MADE: 10-AUG-00 ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOTLINE 2 FLUID WARMER SIMS LEVEL 1, INC. 510(k) NO: K001764(TRADITIONAL) ATTN: GABRIEL J MURACA JR. PHONE NO : 781-878-8011 160 WEYMOUTH ST. SE DECISION MADE: 09-AUG-00 ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 SIMS PORTEX LTD. 510(k) NO: K001555(TRADITIONAL) ATTN: STEVEN M OGILVIE PHONE NO : 441 303 260551 HYTHE SE DECISION MADE: 02-AUG-00 HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NLITE SYSTEM, SLS MODEL NUMBER A00-1025 SLS BIOPHILE LTD. 510(k) NO: K000811(TRADITIONAL) ATTN: MICHAEL KIERNAN PHONE NO : 441 554 755444 UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 25-AUG-00 DAFEN PARC 510(k) SUMMARY AVAILABLE FROM FDA LLANELLI, UNITED KINGDOM DEVICE: HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE SMITH & NEPHEW ENT. 510(k) NO: K002021(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 24-AUG-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR PORP AND TORP MODEL TBD SMITH & NEPHEW ENT. 510(k) NO: K002378(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 29-AUG-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW OFF-CENTERED PORP SMITH & NEPHEW ENT. 510(k) NO: K002464(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 29-AUG-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM SMV AMERICA 510(k) NO: K001681(TRADITIONAL) ATTN: FRANCOIS ROCHE PHONE NO : 330-425-1340 8380 DARROW RD. SE DECISION MADE: 25-AUG-00 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANA DIABECARE SOOIL DEVELOPMENT CO., LTD. 510(k) NO: K001604(TRADITIONAL) ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 14-AUG-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALM PUMP SORENSON MEDICAL INC. 510(k) NO: K002434(SPECIAL) ATTN: R. DOUGLAS JACOB PHONE NO : 801-352-1888 1375 WEST 8040 SOUTH SE DECISION MADE: 23-AUG-00 WEST JORDAN, UT 84088-8320 510(k) STATEMENT DEVICE: TCD 100M, PWD13 TRANSDUCER SPENCER TECHNOLOGIES, INC. 510(k) NO: K002533(TRADITIONAL) ATTN: TONY WILLIAMS PHONE NO : 206-329-7220 701 16TH AVE. SE DECISION MADE: 30-AUG-00 SEATTLE, WA 98122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORQUE INSTRUMENT, MODEL 8500 SPINALIGHT, INC. 510(k) NO: K001476(TRADITIONAL) ATTN: T. A COX PHONE NO : 770-420-2333 1620 ALBRITTON DRIVE SE DECISION MADE: 04-AUG-00 SUITE 7 510(k) STATEMENT KENNESAW, GA 30152 DEVICE: BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE SSL AMERICAS, INC. (REGENT MEDICAL510(k) NO: K000421(TRADITIONAL) ATTN: BRADLEY L PUGH PHONE NO : 334-702-2212 3585 ENGINEERING DRIVE SE DECISION MADE: 14-AUG-00 NORCROSS, GA 30092-9214 510(k) STATEMENT DEVICE: STACKHOUSE LENS HOOD, MODEL SA-700/F STACKHOUSE, INC. 510(k) NO: K000605(TRADITIONAL) ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 17-AUG-00 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB STANDARD IMAGING, INC. 510(k) NO: K001825(SPECIAL) ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025 7601 MURPHY DRIVE SE DECISION MADE: 02-AUG-00 MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELKAST PROVEN KNEE SYSTEM STELKAST CO. 510(k) NO: K002281(SPECIAL) ATTN: DONALD A STEVENS PHONE NO : 412-322-8280 800 VINIAL ST. SE DECISION MADE: 17-AUG-00 SUITE B-210 510(k) STATEMENT PITTSBURGH, PA 15212 DEVICE: STOCKERT COMPACT SYSTEM VERSION 2.0 STOECKERT INSTRUMENTE 510(k) NO: K002118(SPECIAL) ATTN: CYNTHIA J. M. NOLTE PHONE NO : 508-643-0453 49 PLAIN STREET SE DECISION MADE: 09-AUG-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM STRYKER ENDOSCOPY 510(k) NO: K993166(TRADITIONAL) ATTN: TODD MILLER PHONE NO : 408-567-9100 2590 WALSH AVE. SE DECISION MADE: 04-AUG-00 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER T3 HELMET, STRYKER T4 HELMET, STRYKER T4 FIBER OPTIC LIG STRYKER INSTRUMENTS 510(k) NO: K002348(SPECIAL) ATTN: SUZANNE VELAZQUEZ PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 15-AUG-00 KALAMAZOO, MI 49001 510(k) STATEMENT DEVICE: MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA SULZER MEDICA 510(k) NO: K002324(SPECIAL) ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306 9900 SPECTRUM DRIVE SE DECISION MADE: 24-AUG-00 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NDO SURGICAL SURGICAL OVERTUBE SURGICAL, INC. 510(k) NO: K002018(TRADITIONAL) ATTN: JEFF CERIER PHONE NO : 877-337-8887 125 HIGH STREET, SUITE 7 SE DECISION MADE: 17-AUG-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPROVED ENLIGHT LV SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K001881(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 22-AUG-00 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPROVED TRY-IN GEL SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K001899(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 28-AUG-00 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES SACRAL BAR SYSTEM SYNTHES (USA) 510(k) NO: K001720(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 24-AUG-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES SCALLOPED DISTAL TIBIA PLATE SYNTHES (USA) 510(k) NO: K001793(TRADITIONAL) ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 17-AUG-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2.4MM CORTEX SCREW, SELF-TAPPING SYNTHES (USA) 510(k) NO: K002271(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 25-AUG-00 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: SYSMEX R-500 SYSMEX CORPORATION OF AMERICA 510(k) NO: K001683(TRADITIONAL) ATTN: NINA GAMPERLING PHONE NO : 847-726-3675 ONE WILDLIFE WAY SE DECISION MADE: 21-AUG-00 LONG GROVE, IL 60047-9596 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIM TE ME NA S.A.R.L. 510(k) NO: K990100(TRADITIONAL) ATTN: JOE HARMS PHONE NO : 813-818-8705 390 SCARLET BLVD SE DECISION MADE: 02-AUG-00 OLDSMAR, FL 34677 510(k) STATEMENT DEVICE: MICRO-MAX, MODEL 319 TEK MARKETING, INC. 510(k) NO: K002404(TRADITIONAL) ATTN: JOHN A HOPE PHONE NO : 215-364-4941 98 RAILROAD DRIVE SE DECISION MADE: 30-AUG-00 WARMINSTER, PA 18974-1454 510(k) STATEMENT DEVICE: CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K002238(SPECIAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL ROAD SE DECISION MADE: 22-AUG-00 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOLUS NEEDLE TERUMO EUROPE N.V. 510(k) NO: K001572(TRADITIONAL) ATTN: M J AERTS PHONE NO : 003 216 381211 RESEARCHPARK ZONE 2 SE DECISION MADE: 14-AUG-00 INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA LEUVEN 3001, BELGIUM 3001 DEVICE: 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K001978(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919-544-4098 1219 LITTLE CREEK RD. SE DECISION MADE: 08-AUG-00 DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD. 510(k) NO: K001127(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 30-AUG-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD. 510(k) NO: K001556(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 21-AUG-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: C-REACTIVE PROTEIN ANTISERUM KIT THE BINDING SITE, LTD. 510(k) NO: K001636(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 24-AUG-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: 3D ACTIVETRAC THE SAUNDERS GROUP 510(k) NO: K001712(TRADITIONAL) ATTN: DOUGLAS G TOMASKO PHONE NO : 952-368-9214 4250 NOREX DR. SE DECISION MADE: 31-AUG-00 CHASKA, MN 55318-3047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L TORAY INDUSTRIES (AMERICA), INC. 510(k) NO: K994198(TRADITIONAL) ATTN: LISA S JONES PHONE NO : 713-664-6775 540 COLLEGE STREET SE DECISION MADE: 25-AUG-00 BELLAIRE, TX 77401-5010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORNIER BIPOLAR RADIAL HEAD PROSTHESIS TORNIER, INC. 510(k) NO: K994041(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 31-AUG-00 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: UTERINE TENACLUM HOOK TOWNE BROTHERS (PVT.), LTD. 510(k) NO: K001818(TRADITIONAL) ATTN: ABDUL GHAFOOR PHONE NO : 92 432 553231 52-B INDUSTRIAL ESTATE SE DECISION MADE: 30-AUG-00 P.O. BOX 108 510(k) STATEMENT SIALKOT, PAKISTAN 51310 DEVICE: ULTRAGUIDE CT-GUIDE 1010 ULTRAGUIDE LTD. 510(k) NO: K002258(TRADITIONAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SOUTH SE DECISION MADE: 08-AUG-00 HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL DYNAMICS SPINAL RETRACTOR UNITED STATES SURGICAL CORP. 510(k) NO: K002008(TRADITIONAL) ATTN: JENNIFER E SCHUCK PHONE NO : 203-845-4512 150 GLOVER AVE. SE DECISION MADE: 16-AUG-00 NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DND 101 UROGYN LTD. 510(k) NO: K001590(TRADITIONAL) ATTN: KENNETH T BURCK PHONE NO : 508-653-5892 34 FAIRWAY CIRCLE SE DECISION MADE: 02-AUG-00 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL USA INSTRUMENTS, INC. 510(k) NO: K001870(TRADITIONAL) ATTN: TORI BRUNS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 14-AUG-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPOTHERM, MODEL 2000I VAPOTHERM, INC. 510(k) NO: K000401(TRADITIONAL) ATTN: WILLIAM NILAND PHONE NO : 410-974-9255 163 CONDUIT ST. SE DECISION MADE: 24-AUG-00 ANNAPOLIS, MD 21401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREATVISION VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K002194(SPECIAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3100 HANSEN WAY M/S E-055 SE DECISION MADE: 18-AUG-00 PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTON VISION 7.0 VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K002312(SPECIAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3100 HANSEN WAY M/S E-055 SE DECISION MADE: 30-AUG-00 PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS VASCA, INC. 510(k) NO: K001633(TRADITIONAL) ATTN: DOUGLAS E FERGUSON PHONE NO : 978-863-4450 3 HIGHWOOD DR. SE DECISION MADE: 24-AUG-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTOR TARGETING SYSTEM VECTOR MEDICAL, INC. 510(k) NO: K001938(TRADITIONAL) ATTN: ERIN MCGURK PHONE NO : 650-327-7719 1886 LODGEPOLE DRIVE SE DECISION MADE: 29-AUG-00 MILTON, FL 32583 510(k) STATEMENT DEVICE: "MAGIC MOBILITY" 4 X 4 WHEELCHAIR VESTIL MANUFACTURING CORPORATION 510(k) NO: K000796(ABBREVIATED) ATTN: RICK MICHAEL PHONE NO : 219-665-7586 900 GROWTH PARKWAY SE DECISION MADE: 11-AUG-00 ANGOLA, IN 46703 510(k) STATEMENT DEVICE: BREAS PV 100 CPAP SYSTEM VITAL SIGNS, INC. 510(k) NO: K001553(TRADITIONAL) ATTN: ANTHONY P MARTINO PHONE NO : 973-790-1330 20 CAMPUS ROAD SE DECISION MADE: 03-AUG-00 TOTOWA, NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V QUICK PATCH VQ CORPORATION 510(k) NO: K993934(TRADITIONAL) ATTN: MICHAEL A PRICE PHONE NO : 513-475-6626 3130 HIGHLAND AVE SE DECISION MADE: 15-AUG-00 THIRD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45219-2374 DEVICE: VYGON 2 FR EPICUTANEO PUR-CATHETER VYGON CORP. 510(k) NO: K993052(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 03-AUG-00 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR VYGON CORP. 510(k) NO: K993442(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVE. SE DECISION MADE: 03-AUG-00 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 WAREPALMY ENTERPRISE LLC (USA) 510(k) NO: K000354(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 EAST COLUMBINE DRIVE SE DECISION MADE: 25-AUG-00 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 WAREPALMY ENTERPRISE LLC (USA) 510(k) NO: K000356(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 603-788-5651 3636 EAST COLUMBINE DRIVE SE DECISION MADE: 25-AUG-00 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE ( WR MEDICAL ELECTRONICS CO. 510(k) NO: K000574(TRADITIONAL) ATTN: PATRICK J ANDERSON PHONE NO : 651-430-9930 123 NO.2ND.STREET SE DECISION MADE: 09-AUG-00 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WMT MODULAR SHOULDER SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K001706(TRADITIONAL) ATTN: LYNNE WITKOWSKI PHONE NO : 901-867-4620 5677 AIRLINE RD. SE DECISION MADE: 16-AUG-00 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEAGE ACETABULAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K002149(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-9971 5677 AIRLINE RD. SE DECISION MADE: 31-AUG-00 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAXIAL DILATOR SET XENTEK MEDICAL, INC. 510(k) NO: K000737(TRADITIONAL) ATTN: JIM EDDINGS PHONE NO : 903-675-1429 6136 FM 1616 SE DECISION MADE: 01-AUG-00 ATHENS, TX 75751 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 317 TOTAL WITH SUMMARIES 246 TOTAL WITH STATEMENTS 71
Updated 9/27/2000
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