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Medical Devices
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August 2000 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-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
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