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510(k)s Final Decisions Rendered for March 1999 |
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DEVICE: BACK-ON-TRAC, MODEL 101BOT
"BACK-ON-TRACK",INC. 510(k) NO: K984190(TRADITIONAL)
ATTN: DAVID A SCIORTINO PHONE NO : 314-947-9086
344 CLARENDON SE DECISION MADE: 15-MAR-99
ST. CHARLES, MO 63301 510(k) STATEMENT
DEVICE: AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
AARON MEDICAL INDUSTRIES 510(k) NO: K984352(TRADITIONAL)
ATTN: J. ROBERT SARON PHONE NO : 727-384-2323
7100 30TH AVE. NORTH SE DECISION MADE: 04-MAR-99
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM U3 FOR CEFUROXIME
AB BIODISK 510(k) NO: K984491(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DALVAGEN 10 SE DECISION MADE: 09-MAR-99
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: SYSTEM U3 FOR CEPHALOTHIN
AB BIODISK 510(k) NO: K984581(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 46 8 7300760
DALVAGEN 10 SE DECISION MADE: 09-MAR-99
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: ETEST
AB BIODISK 510(k) NO: K990297(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760
DALVAGEN 10 SE DECISION MADE: 22-MAR-99
SOLNA, SWEDEN 16956 510(k) STATEMENT
DEVICE: TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
AB BIODISK 510(k) NO: K990685(TRADITIONAL)
ATTN: ANNE BOLMSTROM PHONE NO : 468 730 0760
DALVAGEN 10, S-169 56 SE DECISION MADE: 26-MAR-99
SOLNA, SWEDEN 510(k) STATEMENT
DEVICE: RF
ABBOTT LABORATORIES, INC. 510(k) NO: K990035(TRADITIONAL)
ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062
1921 HURD DR. SE DECISION MADE: 08-MAR-99
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
ABX DIAGNOSTICS, INC. 510(k) NO: K990311(TRADITIONAL)
ATTN: PAT AMTOWER PHONE NO : 949-489-3913
7777 CENTER AVENUE SE DECISION MADE: 31-MAR-99
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
HUNTINGTON BEACH, CA 92647
DEVICE: NORMED BONE TRANSPORT
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K990140(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL STREET SE DECISION MADE: 25-MAR-99
P.O. BOX 1710 510(k) STATEMENT
BROCKTON, MA 02403
DEVICE: SILKAM NONABSORBABLE SILK SURGICAL SUTURE
AESCULAP 510(k) NO: K990089(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 15-MAR-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
AESCULAP 510(k) NO: K990090(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 22-MAR-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR TECHNIQUES' DENTO-VAC
AIR TECHNIQUES, INC. 510(k) NO: K984584(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 22-MAR-99
HICKSVILLE, NY 11802 510(k) STATEMENT
DEVICE: INTEGRITI PATIENT MONITOR
ALLIANCE INSTRUMENTS 510(k) NO: K980688(TRADITIONAL)
ATTN: JIM ROOKS PHONE NO : 360-882-0202
3112 NE 112TH AVE, SUITE C SE DECISION MADE: 16-MAR-99
VANCOUVER, WA 98682 510(k) STATEMENT
DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K990453(TRADITIONAL)
ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235
LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 09-MAR-99
PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT
NINONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: ALLISON MEDICAL INSULIN SYRINGE (AMIS)
ALLISON MEDICAL, INC. 510(k) NO: K984017(TRADITIONAL)
ATTN: JUSTIN FERRIN PHONE NO : 303-795-1618
4301 SOUTH FEDERAL BLVD., SE DECISION MADE: 04-MAR-99
SUITE 116 510(k) STATEMENT
ENGLEWOOD, CO 80110
DEVICE: ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K983879(TRADITIONAL)
ATTN: PAUL D SMOLENSKI PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 22-MAR-99
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVOLASE 532 LASER SYSTEM
AMERICAN LASER CORP. 510(k) NO: K990725(SPECIAL)
ATTN: DANIEL HOFFER PHONE NO : 801-972-1311
1832 SOUTH 3850 WEST SE DECISION MADE: 22-MAR-99
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVOLASE 532 CUTANEOUS LASER SYSTEM
AMERICAN LASER MEDICAL 510(k) NO: K990780(SPECIAL)
ATTN: DANIEL HOEFER PHONE NO : 801-972-1311
1832 SOUTH 3850 WEST SE DECISION MADE: 22-MAR-99
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
ARTERIAL VASCULAR ENGINEERING, INC510(k) NO: K983927(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-667-2511
129 CONCORD RD., SE DECISION MADE: 11-MAR-99
BLDG. #1, 2 & 4 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01831
DEVICE: BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
ARTHREX, INC. 510(k) NO: K983843(TRADITIONAL)
ATTN: SCOTT M DURLACHER PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 12-MAR-99
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
ATLANTIS COMPONENTS, INC. 510(k) NO: K981858(TRADITIONAL)
ATTN: ANDREW ZIEGLER PHONE NO : 617-661-9799
270 THIRD STREET SE DECISION MADE: 22-MAR-99
CAMBRIDGE, MA 02142-1112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMO MINI SPIKE PLUS
B. BRAUN OF AMERICA, INC. 510(k) NO: K983794(TRADITIONAL)
ATTN: MARK S ALSBERGE PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 23-MAR-99
ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
BAUSCH & LOMB INC. 510(k) NO: K983225(TRADITIONAL)
ATTN: YVONNE E MIDDLEFELL PHONE NO : 716-338-8460
1400 N. GOODMAN STREET SE DECISION MADE: 29-MAR-99
ROCHESTER, NY 14692-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOMETER ELITE XL BLOOD GLUCOSE METER
BAYER CORP. 510(k) NO: K984006(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 18-MAR-99
ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI MINI-TORR PLUS, MODEL 6004
BCI INTL., INC. 510(k) NO: K984618(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 25-MAR-99
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF CUTINOVA THIN DRESSING
BEIERSDORF-JOBT, INC. 510(k) NO: K984593(TRADITIONAL)
ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF CUTINOVA HYDRO DRESSING
BEIERSDORF-JOBT, INC. 510(k) NO: K984595(TRADITIONAL)
ATTN: ANGELO R PERIERA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF CUTINOVA CAVITY DRESSING
BEIERSDORF-JOBT, INC. 510(k) NO: K984597(TRADITIONAL)
ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF CUTINOVA FOAM DRESSING
BEIERSDORF-JOBT, INC. 510(k) NO: K984599(TRADITIONAL)
ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 01-MAR-99
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILON DUAL-DRESS
BIO MED SCIENCES, INC. 510(k) NO: K990042(TRADITIONAL)
ATTN: MARK E DILLON PHONE NO : 610-974-8801
101 TECHNOLOGY DR. SE DECISION MADE: 19-MAR-99
BETHLEHEM, PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
BIO-DETEK, INC. 510(k) NO: K984582(TRADITIONAL)
ATTN: MICHAEL R DUPELLE PHONE NO : 800-225-1310
525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 16-MAR-99
PAWTUCKET, RI 02861-4323 510(k) STATEMENT
DEVICE: ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
BIO-RAD LABORATORIES, INC. 510(k) NO: K990282(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 09-MAR-99
IRVINE, CA 92618-2017 510(k) STATEMENT
DEVICE: ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
BIO-RAD LABORATORIES, INC. 510(k) NO: K990317(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 18-MAR-99
IRVINE, CA 92618-2017 510(k) STATEMENT
DEVICE: ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
BIO-RAD LABORATORIES, INC. 510(k) NO: K990391(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 15-MAR-99
IRVINE, CA 92618-2017 510(k) STATEMENT
DEVICE: ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
BIO-RAD LABORATORIES, INC. 510(k) NO: K990393(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 22-MAR-99
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E
BIO-RAD LABORATORIES, INC. 510(k) NO: K990394(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 18-MAR-99
IRVINE, CA 92618-2017 510(k) STATEMENT
DEVICE: ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
BIO-RAD LABORATORIES, INC. 510(k) NO: K990424(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO RD. SE DECISION MADE: 31-MAR-99
IRVINE, CA 92618-2017 510(k) STATEMENT
DEVICE: ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
BIO-RAD LABORATORIES, INC. 510(k) NO: K990608(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285
9500 JERONIMO ROAD SE DECISION MADE: 30-MAR-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990436(TRADITIONAL)
ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166
1425 EAST NEWPORT CENTER DR. SE DECISION MADE: 31-MAR-99
DEERFIELD BEACH, FL 33442 510(k) STATEMENT
DEVICE: ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990481(TRADITIONAL)
ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166
1425 EAST NEWPORT CENTER DRIVE SE DECISION MADE: 17-MAR-99
DEERFIELD BEACH, FL 33442 510(k) STATEMENT
DEVICE: ULTIMAX CORTICAL BONE SCREWS
BIODYNAMIC TECHNOLOGIES, INC. 510(k) NO: K990513(TRADITIONAL)
ATTN: DANNY HODGEMAN PHONE NO : 954-421-3166
1425 EAST NEWPORT CENTER DR. SE DECISION MADE: 17-MAR-99
DEERFIELD BEACH, FL 33442 510(k) STATEMENT
DEVICE: THE BIOPLATE SHUNT CONNECTOR
BIOMEDICS 510(k) NO: K984583(TRADITIONAL)
ATTN: BRUCE F MACKLER PHONE NO :
536 RIMPAU BOULEVARD SE DECISION MADE: 15-MAR-99
LOS ANGELES, CA 90020 510(k) STATEMENT
DEVICE: TITANIUM FEMORAL COMPONENT
BIOMET, INC. 510(k) NO: K981996(TRADITIONAL)
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 10-MAR-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MAXIM REMOVABLE MOLDED POLY TIBIA
BIOMET, INC. 510(k) NO: K984623(TRADITIONAL)
ATTN: FRED MCCLURE PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 05-MAR-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: LACTOSORB BONE PIN
BIOMET, INC. 510(k) NO: K990291(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 23-MAR-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSACA SYSTEM
BIOSYS AB (PUBL) 510(k) NO: K984580(TRADITIONAL)
ATTN: JANE B CAMPBELL PHONE NO : 914-469-4289
485 LAROE ROAD SE DECISION MADE: 12-MAR-99
CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTITAK SS BUTTONS
BONUTTI RESEARCH 510(k) NO: K990156(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412
2600 SOUTH RANEY SE DECISION MADE: 05-MAR-99
EFFINGHAM, IL 62401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLO
BOSTON BIOMEDICA, INC. 510(k) NO: K980351(TRADITIONAL)
ATTN: DEBRA A PETIT PHONE NO : 508-580-1900
375 WEST ST. SE DECISION MADE: 05-MAR-99
WEST BRIDGEWATER, MA 02379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND G
BOSTON MEDICAL CORP. 510(k) NO: K981947(TRADITIONAL)
ATTN: TIMOTHY F HAND PHONE NO : 800-458-0304
12011 GUILFORD RD. SE DECISION MADE: 03-MAR-99
ANNAPOLIS JUNCTION, MD 20701 510(k) STATEMENT
DEVICE: CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K983171(TRADITIONAL)
ATTN: STEVE JWANOUSKOS PHONE NO : 408-895-3529
2710 ORCHARD PKWY. SE DECISION MADE: 11-MAR-99
SAN JOSE, CA 95113 510(k) STATEMENT
DEVICE: BONE ANCHOR SYSTEM III (BAS III)
BOSTON SCIENTIFIC CORP. 510(k) NO: K990295(TRADITIONAL)
ATTN: LORRAINE M HANLEY PHONE NO : 508-650-8172
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 05-MAR-99
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL
BRAUN AG 510(k) NO: K983295(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 619-458-2277
10421 PACIFIC CENTER COURT SE DECISION MADE: 15-MAR-99
SAN DIEGO, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASO PRESS SYSTEM
BRITT CORP., INC. 510(k) NO: K974393(TRADITIONAL)
ATTN: J. JAMES BRITTON PHONE NO : 732-817-1122
PO BOX 547 SE DECISION MADE: 19-MAR-99
FREEHOLD, NJ 07728 510(k) STATEMENT
DEVICE: TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010
BUSINESS SUPPORT INTL. 510(k) NO: K990923(SPECIAL)
ATTN: DAGMAR S MAESER PHONE NO : 011 312 04289591
AMSTEL 320-I SE DECISION MADE: 31-MAR-99
AMSTERDAM, NETHERLANDS 1017-AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
C.R. BARD, INC. 510(k) NO: K990514(SPECIAL)
ATTN: SANDRA PERREAND PHONE NO : 978-373-1000
25 COMPUTER DR. SE DECISION MADE: 09-MAR-99
HAVERHILL, MA 01832 510(k) STATEMENT
DEVICE: CCD CAMERA, MODEL 9000
CAMTRONICS, LTD. 510(k) NO: K990066(TRADITIONAL)
ATTN: ROBERT KRIEDERMANN PHONE NO : 414-367-0700
MEDICAL SYSTEMS SE DECISION MADE: 17-MAR-99
900 WALNUT RIDGE DR. 510(k) SUMMARY AVAILABLE FROM FDA
HARTLAND, WI 53029
DEVICE: WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHI
CARADYNE, LTD. 510(k) NO: K982283(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 09-MAR-99
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE AST
CARESIDE, INC. 510(k) NO: K990009(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 16-MAR-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
CARESIDE, INC. 510(k) NO: K990036(TRADITIONAL)
ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 18-MAR-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K990691(SPECIAL)
ATTN: DAVID U THOMAS PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 23-MAR-99
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUODERM HYDROACTIVE GEL WOUND DRESSING
CONVATEC, A BRISTOL-MYERS SQUIBB C510(k) NO: K990368(TRADITIONAL)
ATTN: ADRIENNE MCNALLY PHONE NO : 908-904-2630
200 HEADQUARTERS PARK DR. SE DECISION MADE: 26-MAR-99
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HA ABSORBENT WOUND DRESSING
CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K984388(TRADITIONAL)
ATTN: ADRIIENNE MCNALLY PHONE NO : 908-904-2630
100 HEADQUARTERS PARK DRIVE SE DECISION MADE: 03-MAR-99
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
CONWAY STUART MEDICAL, INC. 510(k) NO: K983986(TRADITIONAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910
735 PALOMAR ST. SE DECISION MADE: 23-MAR-99
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SE
COOK UROLOGICAL, INC. 510(k) NO: K990072(TRADITIONAL)
ATTN: DEBBIE SCHMIDT PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 25-MAR-99
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPERSURGICAL INFRARED COAGULATOR FOR ENT
COOPERSURGICAL, INC. 510(k) NO: K990855(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-MAR-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRAFILCON A
COOPERVISION, INC. 510(k) NO: K990606(SPECIAL)
ATTN: BONNIE TSYMBAL PHONE NO : 716-385-6810
711 NORTH RD. SE DECISION MADE: 15-MAR-99
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
CORDIS CORP. 510(k) NO: K990805(SPECIAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 15-MAR-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR OCCLUSION SYSTEM
CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K983483(TRADITIONAL)
ATTN: MARTINE D SCHNEIDER PHONE NO : 305-512-6546
14000 N.W. 57TH CT. SE DECISION MADE: 24-MAR-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
CORIN U.S.A. 510(k) NO: K990657(SPECIAL)
ATTN: CRAIG CORRANCE PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 26-MAR-99
SUITE 190 510(k) STATEMENT
TAMPA, FL 33612
DEVICE: IMMUNO-TROL CONTROL CELLS
COULTER CORP. 510(k) NO: K984216(TRADITIONAL)
ATTN: MARION S GAIDE PHONE NO : 305-380-2594
11800 SW 147 AVENUE SE DECISION MADE: 16-MAR-99
MIAMI, FL 33169-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONT
CRANBERRY (M) SDN. BHD. 510(k) NO: K984039(TRADITIONAL)
ATTN: CHONG YOON TAT PHONE NO : 605 545 1055
LOT 85, JALAN PORTLAND, SE DECISION MADE: 29-MAR-99
TASEK INDUSTRIAL ESTATE 510(k) STATEMENT
IPOH PERAK, MALAYSIA 31400
DEVICE: DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
DADE BEHRING, INC. 510(k) NO: K990251(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
BLDG. 500 MAIL BOX 514 SE DECISION MADE: 31-MAR-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: IGG FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K990551(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
P.O. BOX 6101 SE DECISION MADE: 25-MAR-99
ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: IMMUNOGLOBULIN A TEST SYSTEM
DADE BEHRING, INC. 510(k) NO: K990552(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
P.O. BOX 6101 SE DECISION MADE: 25-MAR-99
ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: IGM FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K990553(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
P.O. BOX 6101 SE DECISION MADE: 22-MAR-99
ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION SPECIAL PROTEIN CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K990554(TRADITIONAL)
ATTN: CATHY P CRAFT PHONE NO : 302-631-6280
P.O. BOX 6101 SE DECISION MADE: 22-MAR-99
ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
DANEK MEDICAL, INC. 510(k) NO: K990603(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 10-MAR-99
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAUM NEUROCUT NEUROBIOPSYNEEDLE
DAUM CORP. 510(k) NO: K990278(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 30-MAR-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE
DENTSPLY MIDWEST 510(k) NO: K983105(TRADITIONAL)
ATTN: ROBERT BOOTH PHONE NO : 847-640-5366
901 W. OAKTON STREET SE DECISION MADE: 08-MAR-99
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ACE SPIDER PLATE
DEPUY ACE MEDICAL CO. 510(k) NO: K990392(TRADITIONAL)
ATTN: KATHLEEN DRAGOVICH PHONE NO : 310-414-6213
2260 EAST EL SEGUNDO BLVD. SE DECISION MADE: 23-MAR-99
EL SEGUNDO, CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAF
DERMAPHYLYX, INC. 510(k) NO: K990438(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 25-MAR-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
DEXIDE, INC. 510(k) NO: K990379(SPECIAL)
ATTN: JOHN CORZINE PHONE NO : 817-589-1454
7509 FLAGSTONE DR. SE DECISION MADE: 04-MAR-99
FORT WORTH, TX 76118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
DIAG CORP. 510(k) NO: K984062(TRADITIONAL)
ATTN: TODD KORNMANN PHONE NO : 612-933-4700
14901 DEVEAU PLACE SE DECISION MADE: 24-MAR-99
MINNETONKA, MN 55410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE THYROGLOBULIN MODEL LKTY
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K982466(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 213-776-0180
5700 WEST 96TH STREET SE DECISION MADE: 12-MAR-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K982468(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 213-776-0180
5700 WEST 96TH ST. SE DECISION MADE: 12-MAR-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K983336(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 18-MAR-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBV-VCA IGG ELISA TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K981812(TRADITIONAL)
ATTN: NORMAN JENKINS PHONE NO : 410-995-0450
8775 M CENTRE PARK DRIVE SE DECISION MADE: 04-MAR-99
#559 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21045
DEVICE: DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
DIDECO S.P.A. 510(k) NO: K984322(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781-684-9201
1601 TRAPELO ROAD SE DECISION MADE: 02-MAR-99
WALTHAM, MA 02154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS
DIGIDENT LTD. 510(k) NO: K990049(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINAME PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 12-MAR-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
DILON TECHNOLOGIES INC. 510(k) NO: K984466(TRADITIONAL)
ATTN: LEE H FAIRCHILD PHONE NO : 757-269-4910
12050 JEFFERSON AVE., SE DECISION MADE: 16-MAR-99
SUITE 250 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT NEWS, VA 23606
DEVICE: DRG MEDIUM SCREW SYSTEM
DOLPHIN MEDICAL TECHNOLOGIES, INC.510(k) NO: K990019(TRADITIONAL)
ATTN: MARK G URBANSKI PHONE NO : 941-342-0414
5959 CATTLEMEN LN. SE DECISION MADE: 15-MAR-99
SARASOTA, FL 34232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS H/2
DORNIER SURGICAL PRODUCTS, INC. 510(k) NO: K984591(TRADITIONAL)
ATTN: CAROL WERNECKE PHONE NO : 770-426-1315
1155 ROBERTS BLVD. SE DECISION MADE: 26-MAR-99
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAGER SOLA SERIES, MODELS 1000/700/500/300
DRAGER MEDIZINTECHNIK GMBH 510(k) NO: K984611(ABBREVIATED)
ATTN: FRANK CLANZETT PHONE NO :
53/55 MOISLINGER ALLEE SE DECISION MADE: 29-MAR-99
LUEBECK, GERMANY D-23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
DUTCH OPHTHALMIC USA, INC. 510(k) NO: K983797(TRADITIONAL)
ATTN: MARK W FURLONG PHONE NO : 603-642-8468
ONE LITTLE RIVER RD. SE DECISION MADE: 03-MAR-99
KINGSTON, NH 03848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON
ELLMAN INTL., INC. 510(k) NO: K990146(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-569-1482
1135 RAILROAD AVE., SE DECISION MADE: 17-MAR-99
ELLMAN BLDG. 510(k) STATEMENT
HEWLETT, NY 11557
DEVICE: ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
EM SCIENCE 510(k) NO: K990516(TRADITIONAL)
ATTN: ANNA G BENTLEY PHONE NO : 609-423-6300
480 DEMOCRAT RD. SE DECISION MADE: 31-MAR-99
GIBBSTOWN, NJ 08027 510(k) STATEMENT
DEVICE: EMOX
EMOX 911 CC 510(k) NO: K984081(TRADITIONAL)
ATTN: IVOR DUNCAN PHONE NO : 272 185 46006
P.O. BOX 79 SE DECISION MADE: 17-MAR-99
SOMERSET WEST, SOUTH AFRICA 7129 510(k) STATEMENT
DEVICE: HINGED KNEE
ENCORE ORTHOPEDICS, INC. 510(k) NO: K982160(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 17-MAR-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AROMAPATCH
ENVIS, INC. 510(k) NO: K984345(TRADITIONAL)
ATTN: STEVE WOODY PHONE NO : 828-281-2109
25 HERTIAGE DRIVE SE DECISION MADE: 19-MAR-99
ASHEVILLE, NC 28806 510(k) STATEMENT
DEVICE: ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
ESTECH, INC. 510(k) NO: K990573(TRADITIONAL)
ATTN: ARTHUR BERTOLERO PHONE NO : 925-648-2033
4115 BLACKHAWK PLAZA CIRCLE SE DECISION MADE: 11-MAR-99
#100 510(k) SUMMARY AVAILABLE FROM FDA
DANVILLE, CA 94506
DEVICE: ULTRACISION HARMONIC SCALPEL HAND PIECE
ETHICON ENDO-SURGERY, INC. 510(k) NO: K990430(SPECIAL)
ATTN: RUTH ANN WOOD PHONE NO : 513-483-3486
4545 CREEK RD. SE DECISION MADE: 12-MAR-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXMOOR SUCTION CLEARANCE KIT
EXMOOR PLASTICS LTD. 510(k) NO: K990366(TRADITIONAL)
ATTN: MARGARET BLACKMORE PHONE NO : 018 232 76837
LISIEUX WAY SE DECISION MADE: 05-MAR-99
TAUNTON TA12LB, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGISCOPE OPHTHALMIC CAMERA
EYE TEL IMAGING, INC. 510(k) NO: K990205(TRADITIONAL)
ATTN: KEVIN T QUINN PHONE NO : 703-803-8584
15078 STILLFIELD PLACE SE DECISION MADE: 26-MAR-99
CENTREVILLE, VA 20120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
FERRIS MFG. CORP. 510(k) NO: K984539(TRADITIONAL)
ATTN: THEODORE THORSEN PHONE NO : 630-887-9797
16 WEST 300 83RD ST. SE DECISION MADE: 01-MAR-99
BURR RIDGE, IL 60521 510(k) STATEMENT
DEVICE: FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BAND
FLEXMEDICS CORP. 510(k) NO: K990765(SPECIAL)
ATTN: WILLIAM C CORRIGAN, JR. PHONE NO : 612-939-0900
12400 WHITEWATER DR., #2040 SE DECISION MADE: 15-MAR-99
MINNETONKA, MN 55343 510(k) STATEMENT
DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN BENZODIAZEPINES TES
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K990099(TRADITIONAL)
ATTN: PERRY G RUCKER PHONE NO : 949-595-0673
23561 RIDGE ROUTE DRIVE SE DECISION MADE: 18-MAR-99
SUITE D 510(k) STATEMENT
LAGUNA HILLS, CA 92653
DEVICE: FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN BARBITURATES TEST
FOREFRONT DIAGNOSTICS, INC. 510(k) NO: K990107(TRADITIONAL)
ATTN: PERRY G RUCKER PHONE NO : 949-595-0673
23561 RIDGE ROUTE DRIVE SE DECISION MADE: 18-MAR-99
SUITE D 510(k) STATEMENT
LAGUNA HILLS, CA 92653
DEVICE: GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
GAMBRO HEALTHCARE 510(k) NO: K982414(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018
1185 OAK ST. SE DECISION MADE: 26-MAR-99
LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXATION SYSTEM
GENERAL SURGICAL INNOVATIONS 510(k) NO: K983318(TRADITIONAL)
ATTN: FEROLYN T POWELL PHONE NO : 408-863-2500
10460 BUBB RD. SE DECISION MADE: 01-MAR-99
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GTI-PF4 ELISA
GENETIC TESTING INSTITUTE 510(k) NO: K983379(TRADITIONAL)
ATTN: MICHAEL MOGHADDAM PHONE NO : 414-792-3900
150 NORTH PATRICK BLVD. SE DECISION MADE: 09-MAR-99
BROOKFIELD, WI 53045-5837 510(k) STATEMENT
DEVICE: SAPHLIFT
GENZYME SURGICAL PRODUCTS 510(k) NO: K990062(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 30-MAR-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GILTECH PLUS CONNECTING TUBE SET
GILTECH PLUS, INC. 510(k) NO: K983624(TRADITIONAL)
ATTN: WILLIAM J GILIAM PHONE NO : 717-686-4184
P.O. BOX 728 SE DECISION MADE: 18-MAR-99
MILFORD, PA 18337 510(k) STATEMENT
DEVICE: GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28
GUIDANT CORP. 510(k) NO: K983075(TRADITIONAL)
ATTN: SANDRA SUNDELL PHONE NO : 408-235-4278
3200 LAKESIDE DR. SE DECISION MADE: 03-MAR-99
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 S
GUIDANT CORP. 510(k) NO: K983346(TRADITIONAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995
3200 LAKESIDE DR. SE DECISION MADE: 23-MAR-99
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
GUIDANT CORP. 510(k) NO: K984394(TRADITIONAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995
3200 LAKESIDE DR. SE DECISION MADE: 08-MAR-99
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH H
GUIDANT CORP. 510(k) NO: K990639(SPECIAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-235-4032
3200 LAKESIDE DR. SE DECISION MADE: 25-MAR-99
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95054-2807
DEVICE: VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
GYNECARE, INC. 510(k) NO: K982738(TRADITIONAL)
ATTN: SUSAN M ALOYAN PHONE NO : 415-614-2500
235 CONSTITUTION DR. SE DECISION MADE: 01-MAR-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNEX ELECTRODES
GYNEX CORP. 510(k) NO: K982739(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 12-MAR-99
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALADDIN II MONITORING OXYGEN/AIR MONITOR
HAMILTON MEDICAL, INC. 510(k) NO: K990293(SPECIAL)
ATTN: TIMOTHY Y COWART PHONE NO : 770-985-1498
3371 LENORA CHURCH RD. SE DECISION MADE: 16-MAR-99
SNELLVILLE, GA 30039 510(k) STATEMENT
DEVICE: AUTOMARQER
HAMILTON THORNE RESEARCH 510(k) NO: K990184(TRADITIONAL)
ATTN: DIARMAID DOUGLAS-HAMILTON PHONE NO : 978-921-2050
100 CUMMINGS CENTER SE DECISION MADE: 19-MAR-99
SUITE 102-C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
HARTALEGA SDN BHD 510(k) NO: K990283(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 036 342 177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 09-MAR-99
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: HARWILL MEDICAL CERVITULA CERVICAL SPATULA
HARWILL MEDICAL (PTY) LTD. 510(k) NO: K983202(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P O BOX 4341 SE DECISION MADE: 15-MAR-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: ENTERO-TEST HP, MODEL #102-01
HDC CORP. 510(k) NO: K983119(TRADITIONAL)
ATTN: LEN ROSS PHONE NO : 408-954-1909
2109 O'TOOLE AVE. SE DECISION MADE: 15-MAR-99
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
HEALTHDYNE TECHNOLOGIES, INC. 510(k) NO: K983572(TRADITIONAL)
ATTN: BETSY CORTELLONI PHONE NO : 770-429-2894
1255 KENNESTONE CIRCLE SE DECISION MADE: 19-MAR-99
MARIETTA, GA 30066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECTFLOW ARTERIAL CANNULA
HEARTPORT, INC. 510(k) NO: K990772(SPECIAL)
ATTN: MARIANNE C DRENNAN PHONE NO : 650-482-4405
700 BAY RD. SE DECISION MADE: 23-MAR-99
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOKKI DT
HILLARD WELCH 510(k) NO: K980840(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
STUTTGART, GERMANY SE DECISION MADE: 15-MAR-99
344 ANNABELLE POINT ROAD 510(k) STATEMENT
CENTERVILLE, MA 02632-2402
DEVICE: ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
HOLLISTER, INC. 510(k) NO: K990456(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 25-MAR-99
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
HOWMEDICA OSTEONICS 510(k) NO: K990152(TRADITIONAL)
ATTN: KATE SUTTON PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 15-MAR-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
HOWMEDICA OSTEONICS CORP. 510(k) NO: K990598(SPECIAL)
ATTN: MARYBETH NAUGHTON PHONE NO : 201-825-4900
59 ROUTE 17 SE DECISION MADE: 15-MAR-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSIRIS
HUESTIS MEDICAL 510(k) NO: K981153(TRADITIONAL)
ATTN: TERRY CHWALK PHONE NO : 800-972-9222
68 BUTTONWOOD STREET SE DECISION MADE: 17-MAR-99
PO BOX 718 510(k) STATEMENT
BRISTOL, RI 02807-0718
DEVICE: HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
HUTCHISON INTL., INC. 510(k) NO: K983385(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-986-4440
7475 WISCONSIN AVE., SUITE 850 SE DECISION MADE: 15-MAR-99
BETHESDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NERVE BLOCK INFUSION KIT
I-FLOW CORP. 510(k) NO: K984502(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 04-MAR-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPOGRAPHIC IMAGING MARKER
I.Z.I. MEDICAL PRODUCTS CORP. 510(k) NO: K990242(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 03-MAR-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: TOPOGRAPHIC IMAGING MARKER
I.Z.I. MEDICAL PRODUCTS CORP. 510(k) NO: K990298(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 03-MAR-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: TRANSFX EXTERNAL FIXATION SYSTEM
IMMEDICA, INC. 510(k) NO: K984357(TRADITIONAL)
ATTN: ROY BOGERT PHONE NO : 973-635-9040
100 PASSAIC AVE. SE DECISION MADE: 04-MAR-99
CHATHAM, NJ 07928-2848 510(k) STATEMENT
DEVICE: IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
IMPLEX CORP. 510(k) NO: K983835(TRADITIONAL)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 15-MAR-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDIGO LASEROPTIC TREATMENT SYSTEM
INDIGO MEDICAL, INC. 510(k) NO: K990851(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 513-786-7987
10123 ALLIANCE RD. SE DECISION MADE: 30-MAR-99
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
INDUSTRIELLE ENTWICKLUNG MEDIZINTE510(k) NO: K964235(TRADITIONAL)
ATTN: UWE KORTH PHONE NO : 011 492 40295000
1151 HOPE STREET SE DECISION MADE: 02-MAR-99
STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTURELESS ANCHOR
INNOVASIVE DEVICES, INC. 510(k) NO: K984490(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229
734 FOREST ST. SE DECISION MADE: 01-MAR-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITI DENTAL IMPLANT SYSTEM
INSTITUT STRAUMANN AG 510(k) NO: K983742(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 15-MAR-99
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
INTEGRA LIFESCIENCES CORP. 510(k) NO: K990086(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500
105 MORGAN LN. SE DECISION MADE: 31-MAR-99
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBC FLOPUMP, MODEL 6000
INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K983272(TRADITIONAL)
ATTN: H. DAVID SHOCKLEY, JR PHONE NO : 512-326-3244
4020 SOUTH INDUSTRIAL DR. SE DECISION MADE: 24-MAR-99
SUITE 160 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78744
DEVICE: SYNERGY D2 SPINAL IMPLANTS
INTERPORE CROSS INTL. 510(k) NO: K984578(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 23-MAR-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
INTERPORE CROSS INTL. 510(k) NO: K990131(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 02-MAR-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
INTRACEL CORP. 510(k) NO: K990664(SPECIAL)
ATTN: CECILIA MATOS-ROSA PHONE NO : 301-258-5200
1330 PICCARD DR. SE DECISION MADE: 31-MAR-99
ROCKVILLE, MD 20850-4396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHORESOR II,MODEL PM900
IOMED, INC. 510(k) NO: K982668(TRADITIONAL)
ATTN: W.TIM MILLER PHONE NO : 801-975-1191
3385 WEST 1820 SOUTH SE DECISION MADE: 02-MAR-99
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-SIGN V (R&D PROJECT DW267#17)
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990182(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 800-533-6825
175 PINEVIEW DR. SE DECISION MADE: 01-MAR-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: D-SIGN VI (R&D PROJECT DW266#9)
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990235(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 01-MAR-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: MONOPAQUE
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990315(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 04-MAR-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: EXCITE
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K990534(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 19-MAR-99
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: ALLROUND-E (CODE NAME RD 1710)
J.F. JELENKO & CO., INC. 510(k) NO: K984587(TRADITIONAL)
ATTN: TRIDIB DASGUPTA PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 17-MAR-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: JELDENT MULTICRYL
J.F. JELENKO & CO., INC. 510(k) NO: K990056(TRADITIONAL)
ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785
99 BUSINESS PARK DR. SE DECISION MADE: 25-MAR-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: ADVANCED NIBP MODULE
JOHNSON & JOHNSON MEDICAL, INC. 510(k) NO: K982641(TRADITIONAL)
ATTN: DARLENE T KORAB PHONE NO : 813-887-2663
4110 GEORGE ROAD SE DECISION MADE: 29-MAR-99
TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA ENDOSCOPE HOLDER
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K990334(TRADITIONAL)
ATTN: KEVIN A KENNAN PHONE NO : 310-558-1500
600 CORPORATE POINTE SE DECISION MADE: 22-MAR-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROGLOTTOGRAPH
KAY ELEMETRICS CORP. 510(k) NO: K990240(TRADITIONAL)
ATTN: WILLIAM D HARBESON PHONE NO : 973-628-6200
2 BRIDGEWATER LN. SE DECISION MADE: 11-MAR-99
LINCOLN PARK, NJ 07035-1488 510(k) STATEMENT
DEVICE: HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
KAY SEE DENTAL MFG. CO. 510(k) NO: K990306(TRADITIONAL)
ATTN: CLARK SMITH PHONE NO : 816-842-2817
124 EAST MISSOURI AVE. SE DECISION MADE: 03-MAR-99
KANSAS CITY, MO 64106-1294 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEELER PULSAIR 3000 NON CONTACT TONOMETER
KEELER INSTRUMENTS, INC. 510(k) NO: K990257(TRADITIONAL)
ATTN: EUGENE R VAN ARSDALE PHONE NO : 800-523-5620
456 PARKWAY SE DECISION MADE: 25-MAR-99
BROOMALL, PA 19008 510(k) STATEMENT
DEVICE: BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (
KING SYSTEMS CORP. 510(k) NO: K983817(TRADITIONAL)
ATTN: MICHAEL A LEAGRE PHONE NO : 317-776-6823
15011 HERRIMAN BLVD. SE DECISION MADE: 01-MAR-99
NOBLESVILLE, IN 46060 510(k) STATEMENT
DEVICE: LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
LAGLOVE (M) SDN. BHD. 510(k) NO: K990415(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 29-MAR-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
LAGLOVE (M) SDN. BHD. 510(k) NO: K990420(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 29-MAR-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: AURA DYE LASER SYSTEM (ADLS)
LASERSCOPE 510(k) NO: K984424(TRADITIONAL)
ATTN: PAUL H HARDIMAN PHONE NO : 408-943-0635
3052 ORCHARD DR. SE DECISION MADE: 05-MAR-99
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LPULSA SYL-9000 OPHTHALMIC YAG LASER
LIGHT-MED (USA), INC. 510(k) NO: K990075(TRADITIONAL)
ATTN: THOMAS V KEELEY PHONE NO : 949-462-9434
110P VIA ESTRADA SE DECISION MADE: 30-MAR-99
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: ABLATOR ELECTRODE
LINVATEC CORP. 510(k) NO: K983652(TRADITIONAL)
ATTN: LAURA D SENEFF PHONE NO : 727-399-5334
11311 CONCEPT BLVD. SE DECISION MADE: 23-MAR-99
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACL/APS FACS KIT
LOUISVILLE APL DIAGNOSTICS, INC. 510(k) NO: K984102(TRADITIONAL)
ATTN: SILVIA S PIERANGELI PHONE NO : 770-455-7129
3988 FLOWERS RD., ST. 620 SE DECISION MADE: 18-MAR-99
DORAVILLE, GA 30360 510(k) STATEMENT
DEVICE: MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
LS RUBBER SDN BHD 510(k) NO: K980964(TRADITIONAL)
ATTN: MOHAMAD FIRDAOS BIN MOHAMEDPHONE NO : 670-599-3704
2443 FILLMORE STREET SE DECISION MADE: 12-MAR-99
SUITE 135 510(k) STATEMENT
SAN FRANCISCO, CA 91115
DEVICE: MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
LS RUBBER SDN BHD 510(k) NO: K981955(TRADITIONAL)
ATTN: MOHAMAD FIRDOAS BIN MOHAMEDPHONE NO : 607-599-3923
2443 FILLMORE STREET SE DECISION MADE: 15-MAR-99
SUITE 135 510(k) STATEMENT
SAN FRANCISCO, CA 91115
DEVICE: MABIS NB-02 ULTRASONIC NEBULIZER
MABIS HEALTHCARE, INC. 510(k) NO: K990506(TRADITIONAL)
ATTN: STEVEN M BISULCA PHONE NO : 847-680-6811
28690 BALLARD DR. SE DECISION MADE: 11-MAR-99
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
MASTEK, INC. 510(k) NO: K983918(TRADITIONAL)
ATTN: MARCOS V MASSON PHONE NO : 888-406-7447
1200 BINZ, SUITE 1200 SE DECISION MADE: 12-MAR-99
HOUSTON, TX 77004 510(k) STATEMENT
DEVICE: MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
MEDI-GLOBE CORP. 510(k) NO: K990220(TRADITIONAL)
ATTN: MICHELLE L FIELDS PHONE NO : 800-966-1431
6202 SOUTH MAPLE AVE., SE DECISION MADE: 31-MAR-99
SUITE 131 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85283
DEVICE: PRO2 CHECK OXYGEN INDICATOR
MEDICAL TECHNOLOGY SPECIALISTS, IN510(k) NO: K983500(TRADITIONAL)
ATTN: DONALD W MORROW, III PHONE NO : 804-674-0199
6290-D WARWICK RD. SE DECISION MADE: 17-MAR-99
RICHMOND, VA 23224 510(k) STATEMENT
DEVICE: MEDIVISION LAPAROSCOPE
MEDIVISION SCOPE SERVICE CENTER, I510(k) NO: K984434(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 714-563-2772
1440 S. STATE COLLEGE BLVD. SE DECISION MADE: 17-MAR-99
#1D 510(k) STATEMENT
ANAHEIM, CA 92806
DEVICE: MEDLINE EXCEL WHEELCHAIRS
MEDLINE 510(k) NO: K990463(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-949-2639
ONE MEDLINE PLACE SE DECISION MADE: 15-MAR-99
MUNDLELEIN, IL 60060 510(k) STATEMENT
DEVICE: UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
MEDRAD, INC. 510(k) NO: K984418(TRADITIONAL)
ATTN: FRANK W PELC III PHONE NO : 412-767-2400
ONE MEDRAD DRIVE SE DECISION MADE: 11-MAR-99
INIANOLA,, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTEX DERMASCAN C ULTRASONIC SYSTEM
MEDSYS, INC. 510(k) NO: K983945(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 17-MAR-99
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; D
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K990375(SPECIAL)
ATTN: ANN-CHRISTINE JONSSON PHONE NO : 45 44 579000
TONSBAKKEN 16-18 SE DECISION MADE: 09-MAR-99
SKOVLUNDE 510(k) SUMMARY AVAILABLE FROM FDA
COPENHAGEN, DENMARK DK-2740
DEVICE: MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALAN
MEDTRONIC, INC. 510(k) NO: K984271(TRADITIONAL)
ATTN: KAREN CROPPER PHONE NO : 714-779-3694
4633 EAST LA PALMA AVE. SE DECISION MADE: 09-MAR-99
ANAHEIM, CA 92807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
MEDTRONICS INTERVENTIONAL VASCULAR510(k) NO: K990707(SPECIAL)
ATTN: MARK CHARTIER PHONE NO : 978-777-0042
37-A CHERRY HILL DR. SE DECISION MADE: 22-MAR-99
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DA
METRON OPTICS, INC. 510(k) NO: K990264(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 31-MAR-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
MEXPO INTL., INC. 510(k) NO: K990210(TRADITIONAL)
ATTN: TIM THAI PHONE NO : 510-293-6800
2671 MCCONE AVENUE SE DECISION MADE: 29-MAR-99
HAYWARD,, CA 94545 510(k) STATEMENT
DEVICE: MICRINS MICRO ANASTOMOSIS CLAMP
MICRINS MICROSURGICAL INSTRUMENTS,510(k) NO: K982278(TRADITIONAL)
ATTN: BERNHARD TEITZ PHONE NO : 847-549-1410
28438 BALLARD DR. SE DECISION MADE: 26-MAR-99
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE
MICRO-MEDICAL DEVICES, INC. 510(k) NO: K983882(TRADITIONAL)
ATTN: JIM OHNECK PHONE NO : 216-229-8332
11000 CEDAR AVENUE SE DECISION MADE: 15-MAR-99
SUITE 445 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44106
DEVICE: ACTIWATCH
MINI-MITTER CO., INC. 510(k) NO: K983533(TRADITIONAL)
ATTN: JACK E MCKENZIE PHONE NO : 541-593-8639
PO BOX 3386 SE DECISION MADE: 23-MAR-99
SUNRIVER, OR 97707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
MINNTECH CORP. 510(k) NO: K983126(TRADITIONAL)
ATTN: MARK MURPHY PHONE NO : 612-551-2643
14905 28TH AVE. NORTH SE DECISION MADE: 08-MAR-99
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERGEL 20% HYPERTONIC SALINE GEL
MOLNLYCKE HEALTH CARE 510(k) NO: K984370(TRADITIONAL)
ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383
500 BALDWIN TOWER SE DECISION MADE: 01-MAR-99
EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEPITEL NON ADHERENT SILICONE DRESSING
MOLNLYCKE HEALTH CARE 510(k) NO: K984371(TRADITIONAL)
ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383
500 BALDWIN TOWER SE DECISION MADE: 03-MAR-99
EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF MOSS P.E.G. TRAY
MOSS TUBES, INC. 510(k) NO: K984628(TRADITIONAL)
ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032
304 VERONA AVENUE SE DECISION MADE: 17-MAR-99
ELIZABETH, NJ 07208 510(k) STATEMENT
DEVICE: MOSS TUBES, INC. NASAL TUBE - MARK IV
MOSS TUBES, INC. 510(k) NO: K984629(TRADITIONAL)
ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032
304 VERONA AVENUE SE DECISION MADE: 02-MAR-99
ELIZABETH, NJ 07208 510(k) STATEMENT
DEVICE: MOSS GASTROSTOMY TUBE
MOSS TUBES, INC. 510(k) NO: K990389(TRADITIONAL)
ATTN: HARRY SCHLAKMAN PHONE NO : 908-355-6032
304 VERONA AVENUE SE DECISION MADE: 22-MAR-99
ELIZABETH, NJ 07208 510(k) STATEMENT
DEVICE: BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
MURRAY ELECTRONICS 510(k) NO: K983228(TRADITIONAL)
ATTN: KENT C HOFFMAN PHONE NO : 410-771-0380
260 SCHILLING CIRCLE SE DECISION MADE: 15-MAR-99
HUNT VALLEY, MD 21031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUZBEE
MWR ELECTRONICS INDUSTRIAL CO. 510(k) NO: K982173(TRADITIONAL)
ATTN: MANFRED W ROSCHER PHONE NO : 272 151 02653
21 ROSE RD. SE DECISION MADE: 11-MAR-99
GOODWOOD, CAPETOWN, SOUTH AFRICA 510(k) STATEMENT
DEVICE: "TUTODROP 1" AND "TUTODROP 2"
MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K982098(TRADITIONAL)
ATTN: SANJIV KUMAR PHONE NO : 919-678-0680
101 ROSE VALLEY WOODS DR. SE DECISION MADE: 01-MAR-99
CARY, NC 27513 510(k) STATEMENT
DEVICE: TUTOPLUS IV ADMINISTRATION SET
MYCO MEDICAL SUPPLIES, INC. 510(k) NO: K990388(TRADITIONAL)
ATTN: SANJIV KUMAR PHONE NO : 919-678-0680
101 ROSE VALLEY WOODS DR. SE DECISION MADE: 29-MAR-99
CARY, NC 27513 510(k) STATEMENT
DEVICE: PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
NAKANISHI, INC. 510(k) NO: K990646(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 19-MAR-99
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX),
NAKANISHI, INC. 510(k) NO: K990682(TRADITIONAL)
ATTN: HIROJI SEKIGUCHI PHONE NO : 012 896 3380
340 KAMIHINATA, KANUMA-SHI SE DECISION MADE: 24-MAR-99
TOCHIGI-KEN, JAPAN 322 510(k) STATEMENT
DEVICE: BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
NAVION BIOMEDICAL CORP. 510(k) NO: K983476(TRADITIONAL)
ATTN: DONALD A KAY PHONE NO : 781-341-8058
312 TOSCA DR. SE DECISION MADE: 01-MAR-99
STOUGHTON, MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORE (AKA RE/STOR)
NEBL, INC. 510(k) NO: K983164(TRADITIONAL)
ATTN: RAO NIMMAGADDA PHONE NO :
44 TERRACE DR. SE DECISION MADE: 05-MAR-99
WORCHESTER, MA 01609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTUBE
NEUROREGEN, L.L.C. 510(k) NO: K983007(TRADITIONAL)
ATTN: JOHN E BARHAM PHONE NO : 410-838-8090
43 N. BONDS STREET SE DECISION MADE: 22-MAR-99
BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCELSIOR PORCELAIN SYSTEM
NEY DENTAL INC. 510(k) NO: K984427(TRADITIONAL)
ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886
1065 S.W. 30TH AVE. SE DECISION MADE: 15-MAR-99
DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT
DEVICE: SYMBIOCERAM
NEY DENTAL INC. 510(k) NO: K990629(TRADITIONAL)
ATTN: ANDREW J PIETROBONO PHONE NO : 954-429-2886
1065 S.W. 30TH AVE. SE DECISION MADE: 19-MAR-99
DEERFIELD BEACH, FL 33442-8193 510(k) STATEMENT
DEVICE: ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K980737(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 714-240-5260
33051 CALLE AVIADOR SE DECISION MADE: 23-MAR-99
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K981702(TRADITIONAL)
ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978
222 INSTITUTE ST. SE DECISION MADE: 05-MAR-99
SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVISIONAL DENTAL IMPLANT SYSTEM
NOBEL BIOCARE USA, INC. 510(k) NO: K984287(TRADITIONAL)
ATTN: JEFF HAUSHEER PHONE NO : 714-282-4800
22895 EASTPARK DRIVE SE DECISION MADE: 01-MAR-99
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR180-R/OXY
NORTHEAST MONITORING, INC. 510(k) NO: K983576(TRADITIONAL)
ATTN: RODNEY L CAMBRE PHONE NO : 978-440-8348
730 BOSTON POST RD., SUITE 22 SE DECISION MADE: 23-MAR-99
SUDBURY, MA 01776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
OLYMPIC MEDICAL CORP. 510(k) NO: K983229(TRADITIONAL)
ATTN: EDWARD (TED) B WEILER PHONE NO : 206-767-3500
5900 FIRST AVE., SOUTH SE DECISION MADE: 23-MAR-99
SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
OLYMPUS OPTICAL, CO. 510(k) NO: K990687(TRADITIONAL)
ATTN: LAURA STORMS TYLER PHONE NO : 516-844-5688
2 CORPORATE CENTER SE DECISION MADE: 26-MAR-99
MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B)
OPTI-CENTRE LABORATORIES 510(k) NO: K983496(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 29-MAR-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORBSCAN
ORBTEK, INC. 510(k) NO: K984443(TRADITIONAL)
ATTN: PIER CALACINO PHONE NO : 801-484-8777
3030 SOUTH MAIN ST., SUITE 600 SE DECISION MADE: 05-MAR-99
SALT LAKE CITY, UT 84115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNOD
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K984289(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DRIVE SE DECISION MADE: 12-MAR-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990531(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DR. SE DECISION MADE: 12-MAR-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 I
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K990783(TRADITIONAL)
ATTN: ANNE ZAVERTNIK PHONE NO : 716-453-3790
100 INDIGO CREEK DR. SE DECISION MADE: 25-MAR-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER OBL SB ANCHOR / SUTURE COMBINATION
ORTHOPAEDIC BIOSYSTEMS, LTD. 510(k) NO: K982996(TRADITIONAL)
ATTN: JEFFRY B SKIBA PHONE NO : 602-596-4066
15990 N GREENWAY-HAYDEN LOOP SE DECISION MADE: 04-MAR-99
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
OSTEONICS CORP. 510(k) NO: K982798(TRADITIONAL)
ATTN: KATE SUTTON PHONE NO : 201-934-4386
59 ROUTE 17 SE DECISION MADE: 25-MAR-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD. 510(k) NO: K984608(TRADITIONAL)
ATTN: ANDY HOLLINGSWORTH PHONE NO : 441 256 841144
WADE RD. SE DECISION MADE: 09-MAR-99
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) STATEMENT
DEVICE: MACROPORE PROTECTIVE SHEET
PACIFIC MATERIALS AND INTERFACES 510(k) NO: K983360(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 619-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 19-MAR-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSHEER LONG PULSE RUBY LASER
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K982980(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-676-7166
9516 CANDOR OAKS DRIVE SE DECISION MADE: 04-MAR-99
RALEIGH, NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
PANASONIC CORPORATION (PANASONIC) 510(k) NO: K981431(TRADITIONAL)
ATTN: EDWARD M BASILE, ESQ. PHONE NO : 202-737-0500
1730 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 03-MAR-99
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
PANASONIC CORPORATION (PANASONIC) 510(k) NO: K981542(TRADITIONAL)
ATTN: EDWARD M BASILE PHONE NO : 202-737-0500
1730 PENNSYLVANIA AVENUE N.W. SE DECISION MADE: 03-MAR-99
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
PDG PRODUCT DESIGN GROUP, INC. 510(k) NO: K990557(TRADITIONAL)
ATTN: PHIL MUNDY PHONE NO : 604 323 9220
9165 SHAUGHNESSY ST. SE DECISION MADE: 22-MAR-99
VANCOUVER, BC, CANADA V6P 6R9 510(k) STATEMENT
DEVICE: PEREGRINE WET SET, MODEL PD400.00
PEREGRINE SURGICAL LTD. 510(k) NO: K990518(TRADITIONAL)
ATTN: JOHN E RICHMOND PHONE NO : 215-348-0456
4050 D SKYRON DR. SE DECISION MADE: 25-MAR-99
DOYLESTOWN, PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATIO
PHAMATECH 510(k) NO: K990249(TRADITIONAL)
ATTN: CARL MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 22-MAR-99
SAN DIEGO, CA 92126 510(k) STATEMENT
DEVICE: PHILIPS NICOL COLLIMATOR FAMILY
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K990423(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVENUE SE DECISION MADE: 15-MAR-99
P.O. BOX 860 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-4708
DEVICE: VIEWPOINT MICROSCOPE OPTION
PICKER INTL., INC. 510(k) NO: K990860(SPECIAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 30-MAR-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWPOINT PASSIVE TOOL OPTION
PICKER INTL., INC. 510(k) NO: K990868(SPECIAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 30-MAR-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUS FRACTURE HEAD PROSTHESIS
PLUS ORTHOPEDICS 510(k) NO: K990309(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 619-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 15-MAR-99
SAN DIEGO, CA 92121-1194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGRAN HIP PROSTHESIS
PONMED LTD. 510(k) NO: K984492(TRADITIONAL)
ATTN: JEFFREY R SCHIDEMAN PHONE NO : 612-835-4018
7307 GLOUCHESTER DRIVE SE DECISION MADE: 15-MAR-99
EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X
PRECISION BIOLOGIC 510(k) NO: K990296(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 18-MAR-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT
DEVICE: THE.R.MO.FREE
PRESSING NORTH AMERICA, INC. 510(k) NO: K990448(TRADITIONAL)
ATTN: MARTIN A RIGUTTO PHONE NO : 888-340-2373
4311 S.W. RESEARCH WAY SE DECISION MADE: 23-MAR-99
CORVALLIS, OR 97333 510(k) STATEMENT
DEVICE: ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/
PRINCETON BIOMEDITECH CORP. 510(k) NO: K990786(SPECIAL)
ATTN: JEMO KANG PHONE NO : 800-726-2670
4242 U.S. RT. 1 SE DECISION MADE: 26-MAR-99
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATI
PT. IRAMA DINAMIKA LATEX 510(k) NO: K984449(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 62 061 515834
JL. KAPTEN PATTIMURA NO. 23/ SE DECISION MADE: 19-MAR-99
235 MEDAN 21053 510(k) STATEMENT
INDONESIA, INDONESIA
DEVICE: OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
RADIONICS SOFTWARE APPLICATIONS, I510(k) NO: K990326(SPECIAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814
22 TERRY AVE. SE DECISION MADE: 04-MAR-99
BURLINGTON, MA 01803-0658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TIP RF SYSTEM
RADIONICS, INC. 510(k) NO: K984552(TRADITIONAL)
ATTN: JEFFREY R MANNION PHONE NO : 800-466-6814
22 TERRY AVE. SE DECISION MADE: 05-MAR-99
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: RANDOX ALBUMIN
RANDOX LABORATORIES LTD. 510(k) NO: K984494(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 441 849 422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 23-MAR-99
CRUMLIN, CO. 510(k) STATEMENT
ANTRIM BT29 4QY, UNITED KINGDOM BT29 4QY
DEVICE: SPOROX II STERILIZING & DISINFECTING SOLUTION
RECKITT & COLMAN, INC. 510(k) NO: K990703(SPECIAL)
ATTN: SEAN MCNEAR PHONE NO : 973-686-7390
1655 VALLEY RD. SE DECISION MADE: 30-MAR-99
WAYNE, NJ 07474 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARIN
RESOUND CORP. 510(k) NO: K984547(TRADITIONAL)
ATTN: GARY ROESEL PHONE NO : 415-780-7800
220 SAGINAW DRIVE, SE DECISION MADE: 19-MAR-99
SEAPORT CENTRE 510(k) SUMMARY AVAILABLE FROM FDA
REDWOOD CITY, CA 94063
DEVICE: BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
RESPIRONICS, INC. 510(k) NO: K983071(TRADITIONAL)
ATTN: TIMOTHY Y COWART PHONE NO : 770-985-1498
3371 LENORA CHURCH RD SE DECISION MADE: 04-MAR-99
SNELLVILLE, GA 30039 510(k) STATEMENT
DEVICE: RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984521(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 17-MAR-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIE
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984607(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 05-MAR-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990050(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PARKWAY SE DECISION MADE: 26-MAR-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K990460(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 22-MAR-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC FLOWFILL
S & C POLYMER GMBH 510(k) NO: K990108(TRADITIONAL)
ATTN: JURGEN ENGELRECHT PHONE NO : 494 121 8619
ROBERT-BOSCH-STR. 5 SE DECISION MADE: 09-MAR-99
D-25335 510(k) SUMMARY AVAILABLE FROM FDA
ELMSHORN, GERMANY
DEVICE: SAS HCG SERUM CONTROLS
SA SCIENTIFIC, INC. 510(k) NO: K990720(TRADITIONAL)
ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 19-MAR-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SAS HCG URINE CONTROLS
SA SCIENTIFIC, INC. 510(k) NO: K990755(TRADITIONAL)
ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 19-MAR-99
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMP
SABRATEK CORP. 510(k) NO: K983355(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-8169
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 12-MAR-99
HOUSTON, TX 77071-3404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
SCHIFF & CO. 510(k) NO: K982136(TRADITIONAL)
ATTN: ANNE M CESARIO PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENEU SE DECISION MADE: 24-MAR-99
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: FLEXISCOPE OPTOMODUL
SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K984641(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 29-MAR-99
NEWTON, MA 02248 510(k) STATEMENT
DEVICE: PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
SCIENCE INC. 510(k) NO: K990208(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-835-1333
MINNESOTA CENTER, SUITE 1060 SE DECISION MADE: 25-MAR-99
7760 FRANCE AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, MN 55435-5803
DEVICE: ISOBAR SPINAL SYSTEM
SCIENT'X 510(k) NO: K990118(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237
9800 METRIC BLVD. SE DECISION MADE: 22-MAR-99
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN CONTROL INFUSION PUMP
SGARLATO LABORATORIES, INC. 510(k) NO: K990101(TRADITIONAL)
ATTN: THOMAS SGARLATO PHONE NO : 408-399-4638
250 ALMENDRA AVENUE SE DECISION MADE: 19-MAR-99
LOS GATOS, CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990267(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 011 862 157727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-MAR-99
SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT
DEVICE: POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K990299(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 011 862 157727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-MAR-99
SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT
DEVICE: 3D-ANGIO
SIEMENS MEDICAL CORP. 510(k) NO: K984634(TRADITIONAL)
ATTN: MALGORZATA STANEK PHONE NO : 732-321-3950
186 WOOD AVE. SO. SE DECISION MADE: 12-MAR-99
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMFAST
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K982952(TRADITIONAL)
ATTN: KATHRYN B DODD PHONE NO : 925-602-8027
4040 NELSON AVE. SE DECISION MADE: 05-MAR-99
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTI
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K990563(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 19-MAR-99
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY-DIGIT
SITCO, INC. 510(k) NO: K990192(TRADITIONAL)
ATTN: ROBERT H MCCARTHY PHONE NO : 847-463-2001
3456 N. RIDGE AVENUE #100 SE DECISION MADE: 12-MAR-99
ARLINGTON HEIGHTS, IL 60004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOJRAB MICRO-TORP, MODEL 7014-5845
SMITH & NEPHEW ENT. 510(k) NO: K990601(TRADITIONAL)
ATTN: ALICIA FARAGE PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 31-MAR-99
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-THREADED ENDOBUTTON
SMITH & NEPHEW, INC. 510(k) NO: K984550(TRADITIONAL)
ATTN: SUSAN A FINNERAN PHONE NO : 508-261-3772
130 FORBES BLVD. SE DECISION MADE: 01-MAR-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY CEMENTED HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K990369(ABBREVIATED)
ATTN: NEAL DEFIBAUGH PHONE NO : 901-399-5363
1450 BROOKS RD. SE DECISION MADE: 12-MAR-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH S
SONIC INNOVATIONS INC. 510(k) NO: K984518(TRADITIONAL)
ATTN: JEANNETTE S JOHNSON PHONE NO : 801-288-0993
5330 SOUTH 900 EAST, SUITE 240 SE DECISION MADE: 12-MAR-99
SALT LAKE CITY, UT 84117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C1 ULTRASOUND SYSTEM
SONOSITE,INC. 510(k) NO: K990806(TRADITIONAL)
ATTN: HOWARD HOLMAN PHONE NO : 425-487-7602
19807 NORTH CREEK PKWY., #200 SE DECISION MADE: 26-MAR-99
BOTHELL, WA 98011-8214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL
SOUTHLAND PRODUCTS CO., LTD. 510(k) NO: K990746(TRADITIONAL)
ATTN: NG PENG LEONG PHONE NO : 006 674 342777
55 RAJYINDEE RD. SE DECISION MADE: 23-MAR-99
HATYAI SONGKHLA, THAILAND 90119 510(k) STATEMENT
DEVICE: SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
SOUTHLAND PRODUCTS CO., LTD. 510(k) NO: K990751(TRADITIONAL)
ATTN: NG PENG LEONG PHONE NO : 006 674 342777
55 RAJYINDEE RD. SE DECISION MADE: 23-MAR-99
HATYAI SONGKHLA, THAILAND 90119 510(k) STATEMENT
DEVICE: SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
SPORICIDIN INTL. 510(k) NO: K983194(TRADITIONAL)
ATTN: HAROLD E PLANK PHONE NO : 301-231-7700
5901 MONTROSE RD. SE DECISION MADE: 05-MAR-99
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMICA GLENOID COMPONENT
SULZER ORTHOPEDICS, INC. 510(k) NO: K990136(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 01-MAR-99
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K983790(TRADITIONAL)
ATTN: MING SUN PHONE NO : 609-401-1080
604 VPR CENTER SE DECISION MADE: 01-MAR-99
1001 LOWER LANDING RD. 510(k) STATEMENT
BLACKWOOD, NJ 08012
DEVICE: HEMOSLEEVE, MODEL 4.0MM, 5.5MM
SURGICAL LASER TECHNOLOGIES, INC. 510(k) NO: K984018(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-619-3248
147 KEYSTONE DR. SE DECISION MADE: 15-MAR-99
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND SOLO PLUS
SYBRON DENTAL SPECIALTIES,INC 510(k) NO: K990498(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 08-MAR-99
ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MO
SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984364(TRADITIONAL)
ATTN: TED Y SHI PHONE NO : 886 479 87099
2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 02-MAR-99
INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA
CHANG HUA, CHINA (TAIWAN) 509
DEVICE: SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUME
SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984543(TRADITIONAL)
ATTN: TED Y SHI PHONE NO : 886 479 87099
2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 01-MAR-99
INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA
CHANG HUA, CHINA (TAIWAN) 509
DEVICE: SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
SYNTEC-TAICHUNG MEDICAL INSTRUMENT510(k) NO: K984602(TRADITIONAL)
ATTN: TED Y SHI PHONE NO : 886 479 8099
2, KUNG SAN ROAD, CHAUN SHING SE DECISION MADE: 05-MAR-99
INDUSTRIAL ZONE, SHEN KANG 510(k) SUMMARY AVAILABLE FROM FDA
CHANG HUA, CHINA (TAIWAN) 509
DEVICE: MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
SYNTHES SPINE 510(k) NO: K990745(SPECIAL)
ATTN: J0NATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 30-MAR-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: ACCU GUIDE
TAYMAN MEDICAL, INC. 510(k) NO: K984382(TRADITIONAL)
ATTN: VAUGHN WEEKS PHONE NO : 414-632-0355
621 16TH STREET SE DECISION MADE: 05-MAR-99
RACINE, WI 53403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATURAL BRAND ACUPUNCTURE NEEDLES
TCM SUPPLY CORP. 510(k) NO: K983671(TRADITIONAL)
ATTN: WILLIAM HUNG LEE PHONE NO : 909-628-9698
12490 CENTRAL AVE., SUITE 221 SE DECISION MADE: 04-MAR-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISPORT X AND TISPORT XC
TISPORT 510(k) NO: K990555(TRADITIONAL)
ATTN: SANDRA GLADSTONE PHONE NO : 509-586-6117
1426 EAST THIRD AVENUE SE DECISION MADE: 22-MAR-99
KENNEWICK, WA 99337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILI
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K990134(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR./P.O. BOX SE DECISION MADE: 19-MAR-99
2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92680-2068
DEVICE: SSA-320A JUST VISION 200/ SSA-325A JUST VISION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K990490(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR./P.O. BOX SE DECISION MADE: 02-MAR-99
2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92680-2068
DEVICE: ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
TRANSFUSION TECHNOLOGIES CORP. 510(k) NO: K982660(TRADITIONAL)
ATTN: JOHN J SOKOLOWSKI PHONE NO : 508-655-2277
9 ERIE DR. SE DECISION MADE: 30-MAR-99
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSHEATH
VISION SCIENCES, INC. 510(k) NO: K990354(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO :
9 STRATHMORE ROAD SE DECISION MADE: 31-MAR-99
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VNUS CLOSURE SYSTEM
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K982816(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 408-747-1200
238 EAST CARIBBEAN DR. SE DECISION MADE: 17-MAR-99
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECLUDE ACUSEAL DURA SUBSTITUTE
W.L. GORE & ASSOC., INC. 510(k) NO: K984534(TRADITIONAL)
ATTN: JOHN NICHOLSON PHONE NO : 520-779-2771
3750 WEST KILTIE LN. SE DECISION MADE: 15-MAR-99
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO AUTOKIT LP(A)
WAKO CHEMICALS, USA, INC. 510(k) NO: K981446(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 09-MAR-99
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: `THE INSEMINATOR' (PROPOSED)
WALLACH SURGICAL DEVICES, INC. 510(k) NO: K984306(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-799-2000
235 EDISON RD. SE DECISION MADE: 01-MAR-99
ORANGE, CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
WEMBLEY RUBBER PRODUCTS (M) SDN BH510(k) NO: K982600(TRADITIONAL)
ATTN: CHOW YUE WAH PHONE NO : 011 603 8461486
PERU BANDAR BARU SALAK TINGGI SE DECISION MADE: 12-MAR-99
43900 SEPANG 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR, MALAYSIA, MALAYSIA
DEVICE: WILSON-COOK BIPOLAR PROBE
WILSON-COOK MEDICAL, INC. 510(k) NO: K990145(TRADITIONAL)
ATTN: PAULA JOYCE PHONE NO : 910-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 25-MAR-99
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESOPHAGEAL INTUBATION DETECTOR
WOLFE TORY MEDICAL, INC. 510(k) NO: K990556(TRADITIONAL)
ATTN: TIM WOLFE PHONE NO : 801-281-3000
79 WEST 4500 SOUTH, SUITE 21 SE DECISION MADE: 26-MAR-99
SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM VERSALOK
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K990708(SPECIAL)
ATTN: DAN REGAN PHONE NO : 800-238-7188
5677 AIRLINE RD. SE DECISION MADE: 30-MAR-99
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSOM CARD PREGNANCY TEST, MODEL 103
WYNTEK DIAGNOSTICS, INC. 510(k) NO: K990576(TRADITIONAL)
ATTN: SHU-CHING CHENG PHONE NO : 619-452-3198
6146 NANCY RIDGE DR., SE DECISION MADE: 09-MAR-99
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: OSOM CARD II HCG-URINE TEST, MODEL 102
WYNTEK DIAGNOSTICS, INC. 510(k) NO: K990578(TRADITIONAL)
ATTN: SHU-CHING CHENG PHONE NO : 619-452-3198
6146 NANCY RIDGE DR., SE DECISION MADE: 09-MAR-99
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION G
YTY INDUSTRY (MANJUNG) SDN. BHD. 510(k) NO: K990013(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 23-MAR-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K983656(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 18-MAR-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY EL
ZEUS SCIENTIFIC, INC. 510(k) NO: K984138(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 23-MAR-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: GLIADIN IGA ELISA TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K990207(TRADITIONAL)
ATTN: MARK K KOPNITSKY PHONE NO : 908-526-3744
P.O. BOX 38 SE DECISION MADE: 26-MAR-99
RARITAN, NJ 08869 510(k) STATEMENT
DEVICE: ZOLL M SERIES SPO2 OPTION
ZOLL MEDICAL CORP. 510(k) NO: K982992(TRADITIONAL)
ATTN: MAURA MCGUIRE PHONE NO : 800-242-9150
32 SECOND AVE. SE DECISION MADE: 11-MAR-99
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODI
ZYMETX, INC. 510(k) NO: K984596(TRADITIONAL)
ATTN: CRAIG D SHIMASAKI PHONE NO : 405-271-1314
800 RESEARCH PKWY., SUITE 100 SE DECISION MADE: 04-MAR-99
OKLAHOMA CITY, OK 73104 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 296
TOTAL WITH SUMMARIES 190
TOTAL WITH STATEMENTS 106
Updated 5/20/2000
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