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510(k)s Final Decisions Rendered for July 1999 |
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DEVICE: EMS SWISS ORTHOCLAST
(EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K991588(TRADITIONAL)
ATTN: SHEILA HAMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 21-JUL-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS SURFACE MOUNT SCALER
(EMS SA) ELECTRO MEDICAL SYSTEMS 510(k) NO: K991874(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 30-JUL-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERTILIZATION MEDIA-HTF
INTL., INC. 510(k) NO: K991173(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453
170 FORT PATH RD., UNIT 14 SE DECISION MADE: 19-JUL-99
MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
A.P. TOTAL CARE, INC. 510(k) NO: K991870(TRADITIONAL)
ATTN: LUIS P LEON PHONE NO : 203-335-9277
70 HAWLEY AVE, SE DECISION MADE: 30-JUL-99
PO BOX 6216 510(k) STATEMENT
BRIDGEPORT, CT
DEVICE: AWARE PAD
AAC CONSULTING GROUP, INC. 510(k) NO: K991469(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-986-4440
7475 WISCONSIN AVE., SUITE 850 SE DECISION MADE: 20-JUL-99
BETHESDA, MD 20814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF),
ABBOTT LABORATORIES, INC. 510(k) NO: K991605(TRADITIONAL)
ATTN: MICHELLE B ROEDING PHONE NO : 408-567-3781
5440 PATRICK HENRY DR. SE DECISION MADE: 09-JUL-99
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
ACCURAY, INC. 510(k) NO: K984563(TRADITIONAL)
ATTN: LUANNE TERMEER PHONE NO : 408-522-3740
570 DEL REY AVE. SE DECISION MADE: 14-JUL-99
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE 2.5
ADAC LABORATORIES 510(k) NO: K991607(TRADITIONAL)
ATTN: DENNIS W HENKELMAN PHONE NO : 408-468-3989
540 ALDER DR. SE DECISION MADE: 26-JUL-99
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
ADAM SPENCE CORP. 510(k) NO: K983940(TRADITIONAL)
ATTN: CAROL ROSENBLOOM PHONE NO : 732-681-7070
1746 RT. 34 SE DECISION MADE: 15-JUL-99
WALL, NJ 07719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
ADVENTURE IN COLORS, INC. 510(k) NO: K992054(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 07-JUL-99
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
AESCULAP-MEDITEC NORTH AMERICA 510(k) NO: K991285(TRADITIONAL)
ATTN: WILLIAM KELLEY PHONE NO : 949-660-2770
2525 MCGAW AVE. SE DECISION MADE: 12-JUL-99
IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K991546(TRADITIONAL)
ATTN: JOAN ZACHAROPOULOS PHONE NO : 914-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 30-JUL-99
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991992(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD., K SE DECISION MADE: 13-JUL-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "RAPIDONE" - MARIJUANA TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K990818(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 07-JUL-99
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: "RAPIDONE" - OPIATES TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K990820(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 15-JUL-99
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: "RAPIDONE - COCAINE TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K990822(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 15-JUL-99
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: DBSET MULTIDRUG SCREEN TEST KIT
AMERITEK, INC. 510(k) NO: K990681(TRADITIONAL)
ATTN: K. C. YEE PHONE NO : 206-527-5086
7030 35TH AVE., N.E. SE DECISION MADE: 15-JUL-99
SEATTLE, WA 98115 510(k) STATEMENT
DEVICE: WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
ANALOGIC CORP. 510(k) NO: K991626(SPECIAL)
ATTN: GARET VAN GENNEP PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 02-JUL-99
PEABODY, MA 01960 510(k) STATEMENT
DEVICE: LIFESTYLES XTRA PLEASURE
ANSELL, INC. 510(k) NO: K983518(TRADITIONAL)
ATTN: LON MCILVAIN PHONE NO : 334-794-4231
1500 INDUSTRIAL RD. SE DECISION MADE: 06-JUL-99
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSELL CONDOMS
ANSELL, INC. 510(k) NO: K984392(TRADITIONAL)
ATTN: LON MCLLVAIN PHONE NO : 334-794-4231
1500 INDUSTRIAL ROAD SE DECISION MADE: 21-JUL-99
DOTHAN, AL 36302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APPLIED BIOTECH SURESTEP DRUG SCREEN MULTI TEST (2)
APPLIED BIOTECH, INC. 510(k) NO: K991816(TRADITIONAL)
ATTN: ROGER KOTTER PHONE NO : 619-587-6771
10237 FLANDERS CT. SE DECISION MADE: 28-JUL-99
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: AVE GL-1 GUIDING CATHETER
ARTERIAL VASCULAR ENGINEERING MASS510(k) NO: K984482(TRADITIONAL)
ATTN: NORMA J LEMAY PHONE NO : 978-667-2511
129 CONCORD ROAD SE DECISION MADE: 30-JUL-99
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
ARTERIAL VASCULAR ENGINEERING, INC510(k) NO: K984627(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-671-3361
129 CONCORD ROAD SE DECISION MADE: 27-JUL-99
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
ASAHI MEDICAL CO., LTD. 510(k) NO: K991512(TRADITIONAL)
ATTN: DAVID L WEST PHONE NO : 301-548-0504
15825 SHADY GROVE ROAD, SE DECISION MADE: 29-JUL-99
SUITE 90 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850
DEVICE: MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
ASTRA TECH, INC. 510(k) NO: K990304(TRADITIONAL)
ATTN: NIKLAS LIDSKOG PHONE NO : 781-861-7707
430 BEDFORD ST. SE DECISION MADE: 15-JUL-99
LEXINGTON, MA 02173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER, MODEL TYPE 2101
B & K MEDICAL A/S 510(k) NO: K991937(SPECIAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100
SANDTOFTEN 9 SE DECISION MADE: 30-JUL-99
GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUER ACCESS INJECTION SITE
BAXTER HEALTHCARE CORP. 510(k) NO: K984060(TRADITIONAL)
ATTN: MARY ELLEN SNYDER PHONE NO : 847-270-4644
CLINTEC NUTRITION CO. SE DECISION MADE: 26-JUL-99
ROUTE 120 AND WILSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ROUND LAKE, IL 60073
DEVICE: RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DI
BAXTER RESEARCH MEDICAL, INC. 510(k) NO: K991170(TRADITIONAL)
ATTN: JOHN W SMITH PHONE NO : 801-565-6213
6864 SOUTH 300 WEST SE DECISION MADE: 02-JUL-99
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD
BAYER CORP. 510(k) NO: K990649(TRADITIONAL)
ATTN: GEORGE M TANCOS PHONE NO : 219-262-6928
1884 MILES AVE. SE DECISION MADE: 09-JUL-99
ELKHART, IN 46515-2004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
BAYER CORP. 510(k) NO: K991817(TRADITIONAL)
ATTN: GABRIEL J MURACA JR. PHONE NO : 914-524-3494
511 BENEDICT AVE. SE DECISION MADE: 22-JUL-99
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL
BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K991702(TRADITIONAL)
ATTN: ANDREA HRONCICCH PHONE NO : 201-847-6173
ONE BECTON DR SE DECISION MADE: 28-JUL-99
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOPHARE D 530 LDR SURGICAL LIGHT
BERCHTOLD GMBH & CO. 510(k) NO: K990656(TRADITIONAL)
ATTN: WOLFRAM K HILL PHONE NO : 004 974 61181370
LUDWIGSTALER STR. 25 SE DECISION MADE: 20-JUL-99
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
BIOCHECK, INC. 510(k) NO: K991741(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 22-JUL-99
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: SCARAID SILICONE GEL SHEETING
BIODERMIS CORP. 510(k) NO: K992146(TRADITIONAL)
ATTN: JEFF S SCHLEUNING PHONE NO : 800-322-3729
3078 EAST SUNSET RD. SUITE #1 SE DECISION MADE: 30-JUL-99
LAS VEGAS, NV 89120 510(k) STATEMENT
DEVICE: AGC V2 REVISION KNEE SYSTEM
BIOMET, INC. 510(k) NO: K984054(TRADITIONAL)
ATTN: PATRICIA BERES PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
BIOMET, INC. 510(k) NO: K991708(ABBREVIATED)
ATTN: DALENE HUFZIGER BINKLEY PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: LACTOSORB HAND SYSTEM
BIOMET, INC. 510(k) NO: K991763(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: TITANIUM LOW PROFILE SCREWS
BIOMET, INC. 510(k) NO: K991807(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 08-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
BIOMET, INC. 510(k) NO: K992058(SPECIAL)
ATTN: MARY L VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 01-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: PERFORMANCE KNEE SYSTEM
BIOMET, INC. 510(k) NO: K992167(SPECIAL)
ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 28-JUL-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOTHANE PATIENT RESTRAINT
BIOPLASTICS 510(k) NO: K991591(TRADITIONAL)
ATTN: CLAIRE BORON PHONE NO : 440-327-0485
34655 MILLS ROAD SE DECISION MADE: 29-JUL-99
N. RIDGEVILLE, OH 44039 510(k) STATEMENT
DEVICE: BIOSACA SYSTEM, MODEL 800
BIOSYS AB (PUBL) 510(k) NO: K991446(TRADITIONAL)
ATTN: JANE B CAMPBELL PHONE NO : 914-469-4289
485 LAROE ROAD SE DECISION MADE: 23-JUL-99
CHESTER, NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMV BRITE TURBO KIT
BIOTEST DIAGNOSTICS CORP. 510(k) NO: K991650(SPECIAL)
ATTN: PATRICIA E BONNESS PHONE NO : 609-397-8511
66 FORD RD., SUITE 131 SE DECISION MADE: 12-JUL-99
DENVILLE, NJ 07834 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
BIOTRONIK, INC. 510(k) NO: K991169(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 01-JUL-99
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
BOSTON SCIENTIFIC CORP. 510(k) NO: K982326(TRADITIONAL)
ATTN: LAURA MONDANO PHONE NO : 508-650-8173
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 13-JUL-99
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC PIT & FISSURE SEALANT
BOSWORTH CO. 510(k) NO: K991902(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVENUE SE DECISION MADE: 26-JUL-99
SKOKIE, IL 60076-3999 510(k) STATEMENT
DEVICE: EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
BRAINLAB USA, INC. 510(k) NO: K983660(TRADITIONAL)
ATTN: ERIC LINDQUIST PHONE NO : 650-494-7240
3100 HANSEN WAY SE DECISION MADE: 14-JUL-99
BUILDING 4A, MAILSTOP E233 510(k) STATEMENT
PALO ALTO, CA 94304
DEVICE: STAINLESS STEEL SOFT SUTURE WIRE
BREGMA INTERNATIONAL TRADING COMPA510(k) NO: K990355(TRADITIONAL)
ATTN: ASSEM HEDAYAT PHONE NO : 306 934 8270
214-111 RESEARCH DRIVE SE DECISION MADE: 08-JUL-99
SASKATOON, SASKATCHEWAN, CANADA S7510(k) STATEMENT
DEVICE: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K992020(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 26-JUL-99
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
BRIGHTSWAY HOLDINGS SDN BHD 510(k) NO: K992021(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 23-JUL-99
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K991939(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 01-JUL-99
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K991940(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 343 1007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 12-JUL-99
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: SUMMER'S EVE LUBRICATING JELLY
C.B. FLEET CO., INC. 510(k) NO: K990597(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-857-6378
1050 CONNECTICUT AVENUE N.W. SE DECISION MADE: 19-JUL-99
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: PRO-GLASS
CAD CAM VENTURES 510(k) NO: K991844(TRADITIONAL)
ATTN: RON FISHELL PHONE NO : 888-655-5010
3301 COFLANS RD SE DECISION MADE: 21-JUL-99
SUITE 104 510(k) STATEMENT
IRVING, TX 75061
DEVICE: ACIER SUTURES
CARDIO THORACIC SYSTEMS 510(k) NO: K991073(TRADITIONAL)
ATTN: MICHAEL J BILLIG PHONE NO : 408-342-1700
10600 N. TANTAU AVENUE SE DECISION MADE: 30-JUL-99
CUPERTINO, CA 95014-0739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER QUAD CANNULA
CARDIOTHORACIC SYSTEMS, INC. 510(k) NO: K983270(TRADITIONAL)
ATTN: MIKE BILLIG PHONE NO : 408-342-1700
10600 NORTH TANTAU AVE. SE DECISION MADE: 28-JUL-99
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESIDE PT
CARESIDE, INC. 510(k) NO: K991065(TRADITIONAL)
ATTN: NENNETH B ASARCH PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY SE DECISION MADE: 26-JUL-99
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCUMENT THYROID CAL*VER
CASCO-NERL DIAGNOSTICS CORPORATION510(k) NO: K992034(TRADITIONAL)
ATTN: KAREN HICKEY PHONE NO : 207-878-7550
500 RIVERSIDE INDUSTRIAL PKWY. SE DECISION MADE: 23-JUL-99
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
CHROMAVISION MEDICAL SYSTEMS, INC.510(k) NO: K984188(TRADITIONAL)
ATTN: BERTRAM J HUDSON PHONE NO : 972-355-9700
3535 FIREWHEEL DRIVE SE DECISION MADE: 28-JUL-99
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
FLOWER MOUND, TX 75028-2628
DEVICE: SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
CIBA VISION CORP. 510(k) NO: K991403(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 770-418-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 16-JUL-99
DULUTH, GA 30155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROTOOLS
CONCEPTION TECHNOLOGY INC. 510(k) NO: K991104(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 19-JUL-99
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: ENHANCE-S PLUS
CONCEPTION TECHNOLOGY INC. 510(k) NO: K991322(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 26-JUL-99
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
CONMED CORP. 510(k) NO: K992186(TRADITIONAL)
ATTN: IRA D DUESLER, JR PHONE NO : 315-797-8375
310 BROAD ST. SE DECISION MADE: 30-JUL-99
UTICA, NY 13501-1203 510(k) STATEMENT
DEVICE: REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
CONSOLIDATED TECHNOLOGIES INC. 510(k) NO: K992151(TRADITIONAL)
ATTN: E. KAY ROBINSON PHONE NO : 512-445-5100
2170 WOODARD STREET SE DECISION MADE: 14-JUL-99
STE. 100 510(k) STATEMENT
AUSTIN, TX 78744-1832
DEVICE: "STRETTA" INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
CONWAY STUART MEDICAL, INC. 510(k) NO: K991291(TRADITIONAL)
ATTN: DAVID A TUCKER PHONE NO : 408-733-9910
735 PALOMAR ST. SE DECISION MADE: 14-JUL-99
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
COOPERSURGICAL, INC. 510(k) NO: K990348(TRADITIONAL)
ATTN: DEBRA A PEKAR PHONE NO : 203-929-6321
15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE S
COOPERSURGICAL, INC. 510(k) NO: K990349(TRADITIONAL)
ATTN: DEBRA A PARKER PHONE NO : 203-929-6321
15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MOD
COOPERSURGICAL, INC. 510(k) NO: K990350(TRADITIONAL)
ATTN: DEBRA A PEKAR PHONE NO : 203-929-6321
15 FOREST PARKWAY SE DECISION MADE: 26-JUL-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILON CORRECT-TOUCH
CT INTL. 510(k) NO: K984512(TRADITIONAL)
ATTN: MIKE KYLE PHONE NO : 805-544-5572
4349 SANTA FE RD SE DECISION MADE: 12-JUL-99
SAN LUIS OBISPO, CA 93401 510(k) STATEMENT
DEVICE: CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
CYNOSURE, INC. 510(k) NO: K992084(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 12-JUL-99
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE BEHRING BFTII
DADE BEHRING, INC. 510(k) NO: K984501(TRADITIONAL)
ATTN: CAROLYN K GEORGE PHONE NO : 781-826-2073
P.O. BOX 6101 SE DECISION MADE: 28-JUL-99
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: OPUS TROPONIN I CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K991176(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
PO BOX 6101 SE DECISION MADE: 01-JUL-99
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS TROPONIN I (CTN) TEST MODULES
DADE BEHRING, INC. 510(k) NO: K991177(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
PO BOX 6101 SE DECISION MADE: 01-JUL-99
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N PROTEIN STANDARD UY
DADE BEHRING, INC. 510(k) NO: K991705(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 781-826-2073
GLASGOW SITE SE DECISION MADE: 15-JUL-99
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: N LATEX IGE MONO REAGENT
DADE BEHRING, INC. 510(k) NO: K991787(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 07-JUL-99
P.O. BOX 6101 510(k) SUMMARY
NEWARK, DE 19714
DEVICE: SNORE-AID PLUS
DENTAL IMAGINEERS & ASSOCIATES 510(k) NO: K991449(TRADITIONAL)
ATTN: WILLIAM BELFER PHONE NO : 732-493-4747
804 WEST PARK AVE. SE DECISION MADE: 22-JUL-99
OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTEC LD 15 DIODE LASER
DENTEK LASERSYSTEMS PRODUKTIONS GE510(k) NO: K990680(TRADITIONAL)
ATTN: DI WOLFGANG NINAUS PHONE NO : 433 162 65204
GROTTENHOFSTRASSE 3 SE DECISION MADE: 30-JUL-99
GRAZ, AUSTRIA A - 8053 510(k) STATEMENT
DEVICE: GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K992065(SPECIAL)
ATTN: JANET JOHNSON PHONE NO : 219-372-7484
700 ORTHOPAEDIC DR. SE DECISION MADE: 12-JUL-99
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ROCKWOOD CLAVICLE PIN
DEPUY, INC. 510(k) NO: K991649(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 219-372-7455
700 ORTHOPAEDIC DR. SE DECISION MADE: 14-JUL-99
P.O. BOX 988 510(k) SUMMARY
WARSAW, IN 46581-0988
DEVICE: DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
DERMAPHYLYX, INC. 510(k) NO: K991608(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 20-JUL-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
DERMAPHYLYX, INC. 510(k) NO: K991609(TRADITIONAL)
ATTN: ANDREW M REED PHONE NO : 303-431-6796
12106, WEST 75TH LANE SE DECISION MADE: 20-JUL-99
ARVADA, CO 80005-5306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
DEROYAL INDUSTRIES, INC. 510(k) NO: K991525(TRADITIONAL)
ATTN: LOIS MARSH PHONE NO : 423-362-6217
200 DEBUSK LANE SE DECISION MADE: 20-JUL-99
POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
DHD HEALTHCARE CORP. 510(k) NO: K991300(TRADITIONAL)
ATTN: LARRY WEINSTEIN PHONE NO : 800-847-8000
ONE MADISON ST. SE DECISION MADE: 12-JUL-99
WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K983203(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 12-JUL-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K992105(SPECIAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 06-JUL-99
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATR
DIAMETRICS MEDICAL, LTD. 510(k) NO: K980380(TRADITIONAL)
ATTN: J L WALTERS PHONE NO : 494 446 651
SHORT STREET SE DECISION MADE: 14-JUL-99
HIGH WYCOMBE, BUCKS, UNITED KINGDO510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETI-EA-G ASSAY
DIASORIN INC. 510(k) NO: K992191(TRADITIONAL)
ATTN: JUDITH J SMITH PHONE NO :
9175 GUIFORD ROAD SE DECISION MADE: 12-JUL-99
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAREX DRAIN SPONGE
DYNAREX CORP. 510(k) NO: K991694(TRADITIONAL)
ATTN: JOHN G MOULDEN PHONE NO : 914-279-9600
ONE INTERNATIONAL BLVD. SE DECISION MADE: 15-JUL-99
BREWSTER, NY 10509 510(k) STATEMENT
DEVICE: DYNAREX NON-WOVEN SPONGE
DYNAREX CORP. 510(k) NO: K991695(TRADITIONAL)
ATTN: JOHN G MOULDEN PHONE NO : 914-279-9600
ONE INTERNATIONAL BLVD. SE DECISION MADE: 15-JUL-99
BREWSTER, NY 10509 510(k) STATEMENT
DEVICE: ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATO
ELAN HOLDINGS, INC. 510(k) NO: K991789(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 09-JUL-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWISS LITHOCLAST MULTIPURPOSE PROBE
ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K992251(SPECIAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 27-JUL-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEKTA STEREOTACTIC GUIDE
ELEKTA INSTRUMENT AB 510(k) NO: K991636(TRADITIONAL)
ATTN: SVERKER GLANS PHONE NO : 011 468 58725400
21911 ERIE LANE SE DECISION MADE: 20-JUL-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RES
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K991953(TRADITIONAL)
ATTN: BONNIE HOLLY PHONE NO : 371-246-5500
2055 EXECUTIVE DR. SE DECISION MADE: 01-JUL-99
INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RES
ENGINEERED MEDICAL SYSTEMS 510(k) NO: K991955(TRADITIONAL)
ATTN: BONNIE HOLLY PHONE NO : 371-246-5500
2055 EXECUTIVE DR. SE DECISION MADE: 06-JUL-99
INDIANAPOLIS, IN 46241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAMIX 2
ESPE DENTAL AG 510(k) NO: K991913(TRADITIONAL)
ATTN: A. PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 26-JUL-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAL ANGEL
ESTILL MEDICAL TECHNOLOGIES, INC. 510(k) NO: K984640(TRADITIONAL)
ATTN: THOMAS KISTNER PHONE NO : 972-818-1872
17440 N. DALLAS PARKWAY SE DECISION MADE: 01-JUL-99
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75287
DEVICE: XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
EXCEL TECH. LTD. 510(k) NO: K991900(TRADITIONAL)
ATTN: MARK T ZAJAC PHONE NO : 905 829 5300 X297
2892 PORTLAND DR. SE DECISION MADE: 12-JUL-99
OAKVILLE, ONTARIO, CANADA L6H 5W8510(k) STATEMENT
DEVICE: FCI CRAWFORD PROBE INTUBATION SETS
FCI OPHTHALMICS, INC. 510(k) NO: K991238(TRADITIONAL)
ATTN: ANNE BOHSACK PHONE NO : 781-837-4416
P.O. BOX 465 SE DECISION MADE: 08-JUL-99
76 PROSPECT ST. 510(k) STATEMENT
MARSHFIELD HILLS, MA 02051
DEVICE: NASO-LARYNGO-PHARYNGOSCOPE
FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K991560(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 13-JUL-99
NEWTON, MA 02468 510(k) STATEMENT
DEVICE: DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
FISMA, INC. 510(k) NO: K991464(TRADITIONAL)
ATTN: TRACY S BEST PHONE NO : 801-972-0500
3959 WEST 1820 SOUTH SE DECISION MADE: 20-JUL-99
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K991520(TRADITIONAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068
TWO LEDGEMONT CENTER SE DECISION MADE: 30-JUL-99
95 HAYDEN AVE. 510(k) STATEMENT
LEXINGTON, MA 02420
DEVICE: CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3,
GALIL MEDICAL LTD. 510(k) NO: K991272(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEEN ST. SE DECISION MADE: 12-JUL-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
GALIL MEDICAL LTD. 510(k) NO: K991517(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST. SE DECISION MADE: 27-JUL-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRON MC MODIFICATION
GC AMERICA, INC. 510(k) NO: K991774(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH STREET SE DECISION MADE: 09-JUL-99
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: SOLAR 9500 INFORMATION MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K990068(TRADITIONAL)
ATTN: KAREN WEBB PHONE NO : 414-362-3329
8200 WEST TOWER AVE. SE DECISION MADE: 14-JUL-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
GE MEDICAL SYSTEMS, INC. 510(k) NO: K992208(TRADITIONAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 12-JUL-99
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEBAUER'S CHLORIDE FINE NOZZE
GEBAUER CO. 510(k) NO: K991514(TRADITIONAL)
ATTN: DENISE E SPELLMAN PHONE NO : 216-271-5252
9410 ST. CATHERINE AVE. SE DECISION MADE: 16-JUL-99
CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMEX
GENDEX-DEL MEDICAL IMAGING CORP. 510(k) NO: K992037(SPECIAL)
ATTN: JEFFREY N MOELLER PHONE NO : 847-288-7000
11550 WEST KING ST. SE DECISION MADE: 30-JUL-99
FRANKLIN PARK, IL 60131 510(k) STATEMENT
DEVICE: SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
GENICON, LC 510(k) NO: K991382(TRADITIONAL)
ATTN: GARY HABERLAND PHONE NO : 407-273-7619
573 WATERSCAPE WAY SE DECISION MADE: 15-JUL-99
ORLANDO, FL 32808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC CAMERA
GENZYME SURGICAL PRODUCTS CORP. 510(k) NO: K991416(TRADITIONAL)
ATTN: MARY MCNAMARA CULLINANE PHONE NO : 508-643-0460
49 PLAIN STREET SE DECISION MADE: 20-JUL-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTEN
GLOVCO (M) SDN. BHD. 510(k) NO: K991554(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 391 3888
LOT 760, JALAN HAJI SIRAT, SE DECISION MADE: 09-JUL-99
OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
GREINER MEDITECH, INC. 510(k) NO: K992244(TRADITIONAL)
ATTN: DOUG HARRIS PHONE NO : 410-836-8228
260 GATEWAY DRIVE, SUITE 17A SE DECISION MADE: 26-JUL-99
BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
HARRY J. BOSWORTH CO. 510(k) NO: K991489(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 15-JUL-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
HARRY J. BOSWORTH CO. 510(k) NO: K991490(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 15-JUL-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: FASTRAY LC
HARRY J. BOSWORTH CO. 510(k) NO: K991631(TRADITIONAL)
ATTN: MILDRED J BOSWORTH PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE. SE DECISION MADE: 26-JUL-99
SKOKIE, IL 60076 510(k) STATEMENT
DEVICE: CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CON
HARTALEGA SDN BHD 510(k) NO: K991616(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 036 342 177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 14-JUL-99
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MO
HEWLETT-PACKARD GMBH 510(k) NO: K990476(TRADITIONAL)
ATTN: EGON PFEIL PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140 SE DECISION MADE: 22-JUL-99
BOEBLINGEN, GERMANY 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K991535(TRADITIONAL)
ATTN: GARY W ENOS PHONE NO : 330-405-3330
9177 DUTTON DR. SE DECISION MADE: 30-JUL-99
TWINSBURG, OH 44056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS ACCP SYSTEM LINE EXTENSION
HOWMEDICA OSTEONICS CORP. 510(k) NO: K992344(SPECIAL)
ATTN: KATE SUTTON PHONE NO : 201-934-4386
59 ROUTE 17 SE DECISION MADE: 30-JUL-99
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K990712 (TRADITIONAL)
ATTN: MS. KAREN ARIEMMA PHONE NO: 201-760-8187
59 ROUTE 17 SE DECISION MADE: 29-JUL-99
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID IC
HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K990847(TRADITIONAL)
ATTN: CINDY SHOWALTER PHONE NO : 804-979-4000
2400 HUNTER'S WAY SE DECISION MADE: 14-JUL-99
CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS
HUMAGEN FERTILITY DIAGNOSTICS, INC510(k) NO: K990941(TRADITIONAL)
ATTN: CINDY SHOWALTER PHONE NO : 804-979-4000
2400 HUNTER'S WAY SE DECISION MADE: 14-JUL-99
CHARLOTTESVILLE, VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
ICS MEDICAL CORP. 510(k) NO: K991497(TRADITIONAL)
ATTN: DELMAR F BLOEM PHONE NO : 800-289-2150
2227 HAMMOND DR. SE DECISION MADE: 28-JUL-99
SCHAUMBURG, IL 60173-3860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOGENE RAPID MRSA IDENTIFICATION ASSAY
ID BIOMEDICAL CORP. 510(k) NO: K990640(TRADITIONAL)
ATTN: ROBERT N BRYAN PHONE NO : 604 431 9314
8855 NORTHBROOK COURT SE DECISION MADE: 09-JUL-99
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFX MULTI PIN CLAMP
IMMEDICA, INC. 510(k) NO: K991723(TRADITIONAL)
ATTN: ROY BOGERT PHONE NO : 973-635-9040
100 PASSAIC AVE. SE DECISION MADE: 22-JUL-99
CHATHAM, NJ 07928-2848 510(k) STATEMENT
DEVICE: RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
IMMUNO CONCEPTS, INC. 510(k) NO: K992041(TRADITIONAL)
ATTN: ERIC S HOY PHONE NO : 972-247-3616
2280 SPRINGLAKE ROAD SE DECISION MADE: 23-JUL-99
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75234
DEVICE: HEDROCEL ACETABULAR CAGE SYSTEM
IMPLEX CORP. 510(k) NO: K983837(TRADITIONAL)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 01-JUL-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBREX HIP STEM, MODEL 01-128-XXXXX
IMPLEX CORP. 510(k) NO: K991869(ABBREVIATED)
ATTN: ROBERT POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 14-JUL-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRIT-LINE MONITOR III (CLM III)
IN-LINE DIAGNOSTICS CORP. 510(k) NO: K992227(SPECIAL)
ATTN: MATTHEW L HAYNIE PHONE NO : 801-451-9000
117 W. 200 S. SE DECISION MADE: 30-JUL-99
FARMINGTON, UT 84025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-MONO CRYOGRNIC SYSTEM
INFLUENCE, INC. 510(k) NO: K991122(TRADITIONAL)
ATTN: PETER M BICK PHONE NO : 415-546-7700
71 STEVENSON ST., SUITE 1120 SE DECISION MADE: 01-JUL-99
SAN FRANCISCO, CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAPLETAC BONE ANCHOR SYSTEM
INFLUENCE, INC. 510(k) NO: K992277(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 30-JUL-99
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-INTERFERENCE SCREW
INNOVASIVE DEVICES, INC. 510(k) NO: K990454(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 588-460-8229
734 FOREST ST. SE DECISION MADE: 01-JUL-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANESFLOW-DUAL DRIP IV INFUSION SET
INNOVATIVE DESIGN ASSOC. 510(k) NO: K990496(TRADITIONAL)
ATTN: JERRY D VLOKA PHONE NO : 201-760-9550
561 EAST SADDLE RIVER SE DECISION MADE: 01-JUL-99
UPPER SADDLE RIVER, NJ 07458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDESTREAM NEBULIZER
INSPIRED MEDICAL PRODUCTS LTD. 510(k) NO: K991725(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 30-JUL-99
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K983631(TRADITIONAL)
ATTN: EDWARD C HOREY, JR. PHONE NO : 412-854-1133
2990 INDUSTRIAL BLVD. SE DECISION MADE: 01-JUL-99
BETHEL PARK, PA 15102 510(k) STATEMENT
DEVICE: DURAGEN DURAL GRAFT MATRIX
INTEGRA LIFESCIENCES CORP. 510(k) NO: K982180(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500
105 MORGAN LN. SE DECISION MADE: 06-JUL-99
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE
INTEGRA LIFESCIENCES CORP. 510(k) NO: K992216(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
105 MORGAN LANE SE DECISION MADE: 26-JUL-99
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
INVACARE CORP. 510(k) NO: K984295(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 09-JUL-99
P.O. BOX 4028 510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125
DEVICE: SPERM MAINTENANCE MEDIUM WITH GLYCEROL
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991337(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 949-261-7800
2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOVINE SERUM ALBUMIN (BSA)
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991338(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 14-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991341(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991342(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 08-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVP (POLYVINYLPYRROLIDONE)
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991343(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 14-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED HAM'S F-10 WITH ALBUMIN
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991420(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 02-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGER
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991421(TRADITIONAL)
ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 02-JUL-99
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLUX SURGICAL HEADLIGHT
ISOLUX AMERICA 510(k) NO: K991572(TRADITIONAL)
ATTN: STUART L MCGHEE PHONE NO : 941-514-7475
1479 RAILHEAD BLVD. SE DECISION MADE: 08-JUL-99
NAPLES, FL 34110-8444 510(k) STATEMENT
DEVICE: CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
JOHNSON & JOHNSON PROFESSIONALS, I510(k) NO: K991222(TRADITIONAL)
ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404
325 PARAMOUNT DR. SE DECISION MADE: 09-JUL-99
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC
KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K992218(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781-834-9500
180 ENTERPRISE DR. SE DECISION MADE: 30-JUL-99
MARSHFIELD, MA 02050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOMET XK-95 PERFORATOR MOTOR (MI-102)
KOMET MEDICAL 510(k) NO: K991625(TRADITIONAL)
ATTN: COURTNEY S PARADICE PHONE NO : 805-658-8755
2188 KNOLL DRIVE SE DECISION MADE: 30-JUL-99
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: VISER PENILE TUMESCENCE MONITOR
LABORIE MEDICAL TECH CORP. 510(k) NO: K991479(TRADITIONAL)
ATTN: DALE COLEMAN PHONE NO : 802-878-1110
310 HURRICANE LANE #2 SE DECISION MADE: 07-JUL-99
WILLISTON, VT 05495 510(k) STATEMENT
DEVICE: LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABE
LAGLOVE (M) SDN. BHD. 510(k) NO: K992018(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK, SE DECISION MADE: 30-JUL-99
OFF BATU 13, JALAN CHERAS 510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
DEVICE: SCATTERFREE LATERAL EMITTING FIBER
LASER PERIPHERALS, INC. 510(k) NO: K992083(SPECIAL)
ATTN: NANCY L ARNOLD PHONE NO : 612-930-9065
5484 FELTL RD. SE DECISION MADE: 12-JUL-99
MINNETONKA, MN 55343 510(k) STATEMENT
DEVICE: PULSTAR
LASERMED, INC. 510(k) NO: K992061(TRADITIONAL)
ATTN: CALVIN D OSTLER PHONE NO : 801-256-0074
8050 SOUTH 1300 WEST SE DECISION MADE: 30-JUL-99
WEST JORDAN, UT 84088 510(k) STATEMENT
DEVICE: REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
LIFECORE BIOMEDICAL, INC. 510(k) NO: K991114(TRADITIONAL)
ATTN: CAROLYN ANDERSON PHONE NO : 612-368-6324
3515 LYMAN BLVD. SE DECISION MADE: 14-JUL-99
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E9000 SYSTEM
LINVATEC CORP. 510(k) NO: K990524(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-392-6464
11311 CONCEPT BOULEVARD SE DECISION MADE: 15-JUL-99
LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIORC ANCHOR
LINVATEC CORP. 510(k) NO: K990770(TRADITIONAL)
ATTN: LAURA SENEFF PHONE NO : 727-392-6464
11311 CONCEPT BOULEVARD SE DECISION MADE: 30-JUL-99
LARGO, FL 34643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR,
LUCAS MEDICAL INC. 510(k) NO: K983802(TRADITIONAL)
ATTN: DANIEL LUCAS PHONE NO : 714-938-0233
1751 SOUTH DOUGLASS ROAD SE DECISION MADE: 30-JUL-99
ANAHEIM, CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, S
LUDLOW TECHNICAL PRODUCTS 510(k) NO: K991235(TRADITIONAL)
ATTN: KATHLEEN M MURPHY PHONE NO : 413-593-8288
TWO LUDLOW PARK SE DECISION MADE: 08-JUL-99
CHICOPEE, MA 01022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE
MAXXIM MEDICAL, INC. 510(k) NO: K991615(TRADITIONAL)
ATTN: JOYCE MOODY PHONE NO : 813-814-4817
477 COMMERCE BLVD SE DECISION MADE: 30-JUL-99
OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
MAXXIM MEDICAL, INC. 510(k) NO: K992122(TRADITIONAL)
ATTN: PETER GRAHAM PHONE NO : 727-561-2100
477 COMMERCE BLVD SE DECISION MADE: 15-JUL-99
OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
MCKINLEY, INC. 510(k) NO: K991275(TRADITIONAL)
ATTN: JOHN MCINROY PHONE NO : 303-420-9569
4080 YOUNGFIELD ST. SE DECISION MADE: 01-JUL-99
WHEAT RIDGE, CO 80033 510(k) STATEMENT
DEVICE: UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
MEDART CORP. 510(k) NO: K991297(TRADITIONAL)
ATTN: MARILYN M CHOU PHONE NO : 510-832-2130
11772 SORRENTO VALLEY RD. SE DECISION MADE: 12-JUL-99
SUITE 240 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
MEDART CORP. 510(k) NO: K991659(TRADITIONAL)
ATTN: MARILYN M CHOU PHONE NO : 510-832-2130
11772 SORRENTO VALLEY RD. SE DECISION MADE: 29-JUL-99
SUITE 240 510(k) STATEMENT
SAN DIEGO, CA 92121
DEVICE: QUADRATURE WRIST COIL, MODEL 445PH-64
MEDICAL ADVANCES, INC. 510(k) NO: K991434(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 06-JUL-99
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAP
MEDICAL INSTRUMENTATION & DIAGNOST510(k) NO: K991336(TRADITIONAL)
ATTN: TYRONE L HARDY PHONE NO : 619-558-5880
5995 MIRA MESA BLVD. SE DECISION MADE: 12-JUL-99
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: INSULSCAN INSULATION TESTING SYSTEM
MEDICOR CORP. 510(k) NO: K991424(TRADITIONAL)
ATTN: SCOTT B KERRIGAN PHONE NO : 847-918-8445
150 FAIRWAY DR. SE DECISION MADE: 22-JUL-99
SUITE 164 510(k) SUMMARY AVAILABLE FROM FDA
VERNON HILLS, IL 60090
DEVICE: PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BL
MEDISENSE, INC. 510(k) NO: K983504(TRADITIONAL)
ATTN: MICHAEL HALPIN PHONE NO : 781-276-6289
4-A CROSBY DR. SE DECISION MADE: 09-JUL-99
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
MEDISON AMERICA, INC. 510(k) NO: K984639(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-463-2166
6616 OWENS DR. SE DECISION MADE: 12-JUL-99
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDO
MEDISON AMERICA, INC. 510(k) NO: K992155(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 925-463-1830
6616 OWENS DR. SE DECISION MADE: 08-JUL-99
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD
MEDITEC CO., LTD. 510(k) NO: K992328(TRADITIONAL)
ATTN: D. H. CHANG PHONE NO : 823 427 072701
SE DECISION MADE: 21-JUL-99
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDITRON STETHOSCOPE SYSTEM
MEDITRON AS 510(k) NO: K991367(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 301-776-3546
11902 SIMPSON ROAD SE DECISION MADE: 19-JUL-99
CLARKSVILLE, MD 21029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDRAD VISTRON CT INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K991557(SPECIAL)
ATTN: JAN E DOBSCHA PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 21-JUL-99
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
MEDSYS, INC. 510(k) NO: K991211(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 08-JUL-99
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K991389(TRADITIONAL)
ATTN: ANN-CHRISTINE JONSSON PHONE NO : 454 457 9000
TONSBAKKEN 16-18 SE DECISION MADE: 15-JUL-99
SKOVLUNDE 510(k) SUMMARY AVAILABLE FROM FDA
COPENHAGEN, DENMARK DK-2740
DEVICE: MODIFICATION TO FOUNTAIN INFUSION SYSTEM
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K992231(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-2600
1600 WEST MERIT PKWY. SE DECISION MADE: 23-JUL-99
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
METRIKA, INC. 510(k) NO: K991917(TRADITIONAL)
ATTN: YA-CHEN HSU PHONE NO : 408-524-2255
510 OAKMEAD PARKWAY SE DECISION MADE: 12-JUL-99
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTI 1 ML SYRINGE
MICRO THERAPEUTICS, INC. 510(k) NO: K991225(ABBREVIATED)
ATTN: MARIA D OCHOA PHONE NO : 949-837-3700
1062-F CALLE NEGOCIO SE DECISION MADE: 08-JUL-99
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK-SERTER, MODEL 395
MINIMED TECHNOLOGIES, INC. 510(k) NO: K992300(TRADITIONAL)
ATTN: DON SELVEY PHONE NO : 818-362-5958
12744 SAN FERNANDO RD. SE DECISION MADE: 29-JUL-99
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TRUZONE PEAK FLOW METER
MONAGHAN MEDICAL CORP. 510(k) NO: K991212(ABBREVIATED)
ATTN: JAMES A COCHIE PHONE NO : 518-561-7330
5 LATOUR AVE., SUITE 1600 SE DECISION MADE: 01-JUL-99
P.O. BOX 2805 510(k) STATEMENT
PLATTSBURGH, NY 12901
DEVICE: EXCELL 22
MWI, INC. 510(k) NO: K991539(TRADITIONAL)
ATTN: GREGORY A WITHERSPOON PHONE NO : 214-210-4900
4230 SHILLING WAY SE DECISION MADE: 01-JUL-99
DALLAS, TX 75237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHMED GLAUCOMA VALVE IMPLANT
NEW WORLD MEDICAL, INC. 510(k) NO: K991072(TRADITIONAL)
ATTN: A.M. AHMED PHONE NO : 909-466-4304
10763 EDISON COURT SE DECISION MADE: 13-JUL-99
RANCHO CUCAMONGA, CA 91730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIN SNAP-OFF SCREW
NEWDEAL S.A. 510(k) NO: K991477(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 14-JUL-99
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVE, POWDERED, BLUE
NING BO YUJIANG RUBBER & PLASTIC C510(k) NO: K991821(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 01-JUL-99
SPARKS,, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO MECHANICAL LITHOTRIPTOR
NORTHGATE TECHNOLOGIES, INC. 510(k) NO: K990341(TRADITIONAL)
ATTN: CASSY KUREK PHONE NO : 847-608-8900
600 CHURCH RD. SE DECISION MADE: 14-JUL-99
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE M7 ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K991727(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 16-JUL-99
WALTHAM, MA 02254-9141 510(k) STATEMENT
DEVICE: COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
NOVARTIS NUTRITION CORP. 510(k) NO: K991668(TRADITIONAL)
ATTN: ROBERT J LANG PHONE NO : 612-591-2950
5320 WEST 23RD STREET SE DECISION MADE: 26-JUL-99
PO BOX 370 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55440
DEVICE: SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPT
OHIO MEDICAL INSTRUMENT CO., INC. 510(k) NO: K991267(TRADITIONAL)
ATTN: KENNETH B MILLER PHONE NO : 513-561-2705
4900 CHARLEMAR DR. SE DECISION MADE: 12-JUL-99
CINCINNATI, OH 45227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROCAR SYSTEM ACCORDING TO HASSON
OLYMPUS AMERICA, INC. 510(k) NO: K990237(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 516-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 12-JUL-99
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K991377(TRADITIONAL)
ATTN: DEEBIE IAMPIETRO PHONE NO : 978-664-8400
14 EQUESTRIAN DR SE DECISION MADE: 12-JUL-99
N. READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCLERAL PLUGS, 19 AND 20 GAUGE
OPHTHALMIC CONSULTANTS, INC. 510(k) NO: K990872(TRADITIONAL)
ATTN: JOHN E LINCOLN PHONE NO : 435-882-4655
65 N. MAIN, SUITE 101 SE DECISION MADE: 13-JUL-99
PO BOX 154 510(k) SUMMARY AVAILABLE FROM FDA
TOOELE, UT 84074
DEVICE: BICORTICAL SCREW
ORALTRONICS MARKETING-UND VERTRIEB510(k) NO: K983120(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 619-792-1235
4329 GRAYDON RD SE DECISION MADE: 29-JUL-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT
ORATEC INTERVENTIONS, INC. 510(k) NO: K992408(SPECIAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 30-JUL-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUNT TIP TROCAR PORT
ORIGIN MEDSYSTEMS, INC. 510(k) NO: K992353(TRADITIONAL)
ATTN: LORI E ADELS PHONE NO : 650-470-6230
1525 O'BRIEN DR. SE DECISION MADE: 30-JUL-99
MENLO PARK, CA 94025 510(k) STATEMENT
DEVICE: SERUM CROSSLAPS ONE STEP ELISA
OSTEOMETER BIOTECH A/S 510(k) NO: K990843(TRADITIONAL)
ATTN: PER QVIST PHONE NO : 454 494 8900
HERLEV HOVEDGADE 207 SE DECISION MADE: 09-JUL-99
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEONICS HA-COATED DEVICES
OSTEONICS CORP. 510(k) NO: K980070(TRADITIONAL)
ATTN: TERRY SHERIDAN PHONE NO : 281-825-4900
59 ROUTE 17 SE DECISION MADE: 23-JUL-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
OSTEOTECH, INC. 510(k) NO: K991586(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 800-537-9842
51 JAMES WAY SE DECISION MADE: 23-JUL-99
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-LEG (3C100)
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K991590(TRADITIONAL)
ATTN: JOHN HENDRICKSON PHONE NO : 612-533-9464
3000 XENIUM LANE NORTH SE DECISION MADE: 08-JUL-99
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARKER FLEX-TIP TRACHEAL TUBE
PARKER MEDICAL ASSOC. 510(k) NO: K984528(TRADITIONAL)
ATTN: JEFFREY D PARKER PHONE NO : 513-321-1097
109 INVERNESS DRIVE EAST, SE DECISION MADE: 15-JUL-99
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112-5105
DEVICE: ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
PDZ-EUROPA LTD. 510(k) NO: K992163(SPECIAL)
ATTN: ROBERT F MARTIN PHONE NO : 978-369-0617
325COLLEGE ROAD SE DECISION MADE: 13-JUL-99
CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICAT
PERIPHERAL AVE 510(k) NO: K991533(TRADITIONAL)
ATTN: SUSAN WALTON PHONE NO : 707-591-7315
2330 CIRCADIAN WAYY SE DECISION MADE: 29-JUL-99
SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AT HOME DRUG TEST, MODEL 9175
PHAMATECH 510(k) NO: K992217(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO :
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 13-JUL-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
PHARMACIA & UPJOHN CO. 510(k) NO: K991945(TRADITIONAL)
ATTN: KAREN E MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 28-JUL-99
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWPOINT TOOLS- STERRAD
PICKER INTERNATIONAL, INC. 510(k) NO: K983764(TRADITIONAL)
ATTN: HELEN K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 08-JUL-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR SPECTROSCOPY PACKAGE
PICKER INTERNATIONAL, INC. 510(k) NO: K991568(TRADITIONAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 19-JUL-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K982859(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 619-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 30-JUL-99
BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-1194
DEVICE: CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X
PRECISION BIOLOGIC 510(k) NO: K990579(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 23-JUL-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT
DEVICE: CRYOCHECK LA SURE, MODEL SUR25-10
PRECISION BIOLOGIC 510(k) NO: K990580(TRADITIONAL)
ATTN: SANDY MORRISON PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 28-JUL-99
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) STATEMENT
DEVICE: PVS 1400 GUIDEWIRE
PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K990823(TRADITIONAL)
ATTN: JOHN RAGAZZO PHONE NO : 801-585-7069
360 WAKARA WAY SE DECISION MADE: 23-JUL-99
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS STIK, ACCUSIGN STIK
PRINCETON BIOMEDITECH CORP. 510(k) NO: K992068(SPECIAL)
ATTN: JEMO KANG PHONE NO : 800-726-2670
4242 U.S. ROUTE 1 SE DECISION MADE: 06-JUL-99
P.O. BOX 7139 510(k) STATEMENT
MONMOUTH JUNCTION, NJ 08852-1905
DEVICE: MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEM
PROCATH CORP. 510(k) NO: K991001(SPECIAL)
ATTN: JOSEPH C GRIFFIN, III PHONE NO : 609-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 15-JUL-99
575 RT. 73 NORTH, BLDG. D 510(k) STATEMENT
WEST BERLIN, NJ 08091
DEVICE: PASS/FAIL CHALLENGE PACK
PROPPER MFG. CO., INC. 510(k) NO: K991276(TRADITIONAL)
ATTN: JOHN D DYCKMAN PHONE NO : 718-392-6650
36-04 SKILLMAN AVE. SE DECISION MADE: 12-JUL-99
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LAR
PT. BERLIAN GLOVINDO 510(k) NO: K992177(TRADITIONAL)
ATTN: TONY JAP PHONE NO : 626-913-1798
JLN. RAYA MEDAN RANTAU PRAPAT SE DECISION MADE: 29-JUL-99
KM +230 DESA DAMULI 510(k) SUMMARY AVAILABLE FROM FDA
KEC. LABUHAN BATU - N. SUMATRA, INDONESIA
DEVICE: QUALISYS PSA IMMUNOASSAY
QUALISYS DIAGNOSTICS, INC. 510(k) NO: K990234(TRADITIONAL)
ATTN: GRACE KWAN PHONE NO : 949-788-0633
16 TECHNOLOGY DRIVE SE DECISION MADE: 08-JUL-99
SUITE 118 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: MODIFICATION TO GAMMA GUIDANCE SYSTEM
RADIATION MONITORING DEVICES, INC.510(k) NO: K983768(TRADITIONAL)
ATTN: PAUL STOPPEL PHONE NO : 617-929-1167
44 HUNT ST. SE DECISION MADE: 02-JUL-99
WATERTOWN, MA 02472-4699 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TLC PEDIATRIC FRAME, MODEL TLC-SYS
RADIONICS, INC. 510(k) NO: K991523(TRADITIONAL)
ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 30-JUL-99
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDI-TEST COCAINE
REDWOOD BIOTECH INC. 510(k) NO: K991110(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 408-541-8970
520 WEDDELL DRIVE, SUITE 8 SE DECISION MADE: 26-JUL-99
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDI-TEST METHAMPHETAMINE
REDWOOD BIOTECH INC. 510(k) NO: K991504(TRADITIONAL)
ATTN: JANIS FREESTONE PHONE NO : 650-691-4770
2440 LEGHORN ST. SE DECISION MADE: 22-JUL-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SULLIVAN AUTOSET NASAL CPAP SYSTEM
RESMED LTD. 510(k) NO: K984428(TRADITIONAL)
ATTN: SCOTT DUDEVOIR PHONE NO : 619-689-2400
10121 CARROLL CANYON RD SE DECISION MADE: 26-JUL-99
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720
RI MOS. S.R.L. 510(k) NO: K991827(TRADITIONAL)
ATTN: ADENA NORA S RIEMER PHONE NO : 978-371-0066
100 MAIN ST. SE DECISION MADE: 19-JUL-99
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA
DEVICE: COBAS INTEGRA AMIKACIN MAB
ROCHE DIAGNOSTICS CORP. 510(k) NO: K991597(TRADITIONAL)
ATTN: LISA GERARD PHONE NO : 317-576-3362
9115 HAGUE RD. SE DECISION MADE: 22-JUL-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA ACETAMINOPHEN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K991598(TRADITIONAL)
ATTN: LISA GERARD PHONE NO : 317-576-3362
9115 HAGUE RD. SE DECISION MADE: 22-JUL-99
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTE-LITE I LIGHT CURE UNIT
ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K991863(TRADITIONAL)
ATTN: STERLING CHENG PHONE NO : 886 346 31999
18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 19-JUL-99
CHUNGLI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: Q-LITE 75 LIGHT CURE UNIT
ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K991865(TRADITIONAL)
ATTN: STERLING CHENG PHONE NO : 886 344 631999
18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 20-JUL-99
CHUNGLI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: DD URETERAL STENT, INTEGRAL STENT
RUSCH INTL. 510(k) NO: K982974(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 02-JUL-99
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION
SAFESKIN CORP. 510(k) NO: K991951(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 26-JUL-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAMSUNG RAYPAX SYSTEM
SAMSUNG SDS CO., LTD 510(k) NO: K991537(TRADITIONAL)
ATTN: HERMAN OOSTERWJICK PHONE NO : 940-440-9330
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 06-JUL-99
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION P
SCAN-MED, INC. 510(k) NO: K991700(TRADITIONAL)
ATTN: EDWARD C WILSON PHONE NO : 202-637-5839
555 13TH STREET, N.W. SE DECISION MADE: 19-JUL-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
SCHIAPPARELLI BIOSYSTEMS, INC. 510(k) NO: K991733(TRADITIONAL)
ATTN: STEVEN DALESSIO PHONE NO : 973-882-8630
368 PASSAIC AVE. SE DECISION MADE: 13-JUL-99
FAIRFIELD, NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIMED ANGIOGRAPHIC CATHETERS
SCIMED 510(k) NO: K992142(SPECIAL)
ATTN: MELANIE RASKA PHONE NO : 800-553-5878
ONE SCIMED PLACE SE DECISION MADE: 21-JUL-99
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K991849(TRADITIONAL)
ATTN: CHAN CHIN HONG PHONE NO : 605 322 3200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 07-JUL-99
PERINDUSTRIAN BUKIT MERAH 510(k) STATEMENT
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM
SHANGHAI CHANGZHENG LATEX FACTORY 510(k) NO: K992031(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-JUL-99
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
SHANGHAI CHINASTAR CORP. 510(k) NO: K992205(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 23-JUL-99
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHANGHAI CHINASTAR CORP. 510(k) NO: K992206(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 29-JUL-99
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K991457(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 011 862 157727722
#1 BIYU RD.,CANGQIAO TOWNSHIP SE DECISION MADE: 01-JUL-99
SONGJIANG COUNTY 510(k) STATEMENT
SHANGHAI, CHINA
DEVICE: PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K992100(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 011 862 157727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 29-JUL-99
SONGJIANG SHANGHAI, CHINA 510(k) STATEMENT
DEVICE: SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
SHELHIGH, INC. 510(k) NO: K991567(TRADITIONAL)
ATTN: SHLOMO GABBAY PHONE NO : 973-467-7861
67 E. WILLOW STREET SE DECISION MADE: 14-JUL-99
MILLBURN, NJ 07041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EARLOOP FACE MASK
SHUENN BAO SHING CORP. 510(k) NO: K990719(TRADITIONAL)
ATTN: CHARLIE CHEN PHONE NO : 886 225 922288
11TH FL., 35, MIN CHUAN W. RD SE DECISION MADE: 12-JUL-99
TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: RABEA DEVICE, MODEL PXXXXXX
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K990345(TRADITIONAL)
ATTN: THOMAS HOGHAUG PHONE NO : 612-470-9545
27660 WOODSIDE ROAD SE DECISION MADE: 30-JUL-99
SHOREWOOD, MN 55331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETCHING GEL
SILICON-UND COMPOSITE SPEZIALITATE510(k) NO: K991450(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 493 412 18619
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 09-JUL-99
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SD-100 SKYEAR THERMOMETER
SKYLARK DEVICE CO., LTD. 510(k) NO: K984506(TRADITIONAL)
ATTN: GEORGE K C CHEN PHONE NO : 886 225 979005
34 CHUNG SHAN NORTH RD., SE DECISION MADE: 29-JUL-99
12TH FL., SEC. 3 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
SMART GLOVE CORP. SDN BHD 510(k) NO: K991624(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 391 6100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 09-JUL-99
SEMENTA, JALAN KAPAR 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: SMITH & NEPHEW SUTURE LOK
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K991500(TRADITIONAL)
ATTN: SIGI CARON PHONE NO : 508-261-3600
130 FORBES BOULEVARD SE DECISION MADE: 14-JUL-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
SMITH & NEPHEW, INC. 510(k) NO: K991323(TRADITIONAL)
ATTN: DEBORAH CONNORS PHONE NO : 978-749-1000
160 DASCOMB RD. SE DECISION MADE: 06-JUL-99
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY POROUS SIZE 8 HIP STEM
SMITH & NEPHEW, INC. 510(k) NO: K991485(ABBREVIATED)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 12-JUL-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CICACARE MANAGEMENT FOR SCARS
SMITH & NEPHEW, INC. 510(k) NO: K991957(TRADITIONAL)
ATTN: JIM IRVIN PHONE NO : 727-392-1261
11775 STARKEY RD. SE DECISION MADE: 20-JUL-99
LARGO, FL 33773-4727 510(k) STATEMENT
DEVICE: CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
SMITH & NEPHEW, INC. 510(k) NO: K991968(TRADITIONAL)
ATTN: JIM IRVIN PHONE NO : 727-392-1261
11775 STARKEY RD. SE DECISION MADE: 30-JUL-99
LARGO, FL 33773-4727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETENE POLYPROPYLENE MESH
SOFRADIM PRODUCTION 510(k) NO: K991400(TRADITIONAL)
ATTN: MARY MCNAMARA CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 12-JUL-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONT
SPECIALTY ULTRAVISION, INC. 510(k) NO: K984090(TRADITIONAL)
ATTN: IVALEE I COHEN PHONE NO : 408-341-0700
307 ORCHARD CITY DR., #100 SE DECISION MADE: 07-JUL-99
CAMPBELL, CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
STELKAST CO. 510(k) NO: K991622(TRADITIONAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL STREET, SUITE B-210 SE DECISION MADE: 14-JUL-99
PITTSBURGH, PA 15212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNOCTA PROSTHETICS
STRAUMANN USA 510(k) NO: K990342(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 20-JUL-99
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: PRO-PORTION CLEANER/DISINFECTANT
SULTAN CHEMISTS, INC. 510(k) NO: K991509(TRADITIONAL)
ATTN: LES HEIMANN PHONE NO : 201-871-1232
85 WEST FOREST AVE. SE DECISION MADE: 14-JUL-99
ENGLEWOOD, NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HT, MODEL HT PB
SULZER OSCOR, INC. 510(k) NO: K990142(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DESOTO BLVD. SE DECISION MADE: 30-JUL-99
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: OCUSYSTEM ART ADVANTAGE, MODEL 995
SURGICAL DESIGN CORP. 510(k) NO: K991852(TRADITIONAL)
ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340
1050 CONNECTICUT AVENUE, NW SE DECISION MADE: 07-JUL-99
WASHINGTON, DC 20036-5339 510(k) STATEMENT
DEVICE: IMMERGE IMAGE CORRELATION
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K991468(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 06-JUL-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIBOND SOLO PLUS 2
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K991808(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 09-JUL-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES (USA) 510(k) NO: K990965(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 01-JUL-99
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES CRANIAL FLAP TWIST CLAMP
SYNTHES (USA) 510(k) NO: K991860(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 20-JUL-99
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES CRANIAL FLAP TUBE CLAMP
SYNTHES (USA) 510(k) NO: K992000(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 20-JUL-99
P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE
SYNTRON BIORESEARCH, INC. 510(k) NO: K992207(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVE. SE DECISION MADE: 22-JUL-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: TAMPA HYPERBARIC MONOPLACE CHAMBER
TAMPA HYPERBARIC ENT. 510(k) NO: K981938(TRADITIONAL)
ATTN: MICHAEL CAPRIA PHONE NO : 813-935-4404
700 WEST WATERS AVE. SE DECISION MADE: 06-JUL-99
TAMPA, FL 33604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
TECSA TECHNICAL SERVICES 510(k) NO: K990602(TRADITIONAL)
ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312
1205 DE LA VINA SE DECISION MADE: 01-JUL-99
SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX STERILE SURGICAL GLOVES
TG MEDICAL SDN BHD 510(k) NO: K992219(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 30-JUL-99
OFF JLN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050
DEVICE: FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
THERMOQUEST CORP. 510(k) NO: K991408(TRADITIONAL)
ATTN: RICHARD L MILLER PHONE NO : 740-373-4763
MILL CREEK ROAD SE DECISION MADE: 19-JUL-99
MARIETTA, OH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOPLATE
TOKAI HIT CO., LTD. 510(k) NO: K991263(TRADITIONAL)
ATTN: HIDEHARU TSUCHIYA PHONE NO : 815 442 46699
306-1 GENDOJI-CHO SE DECISION MADE: 08-JUL-99
FUJINOMIYA-SHI, SHIZUOKA-KEN, JAPA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISTITE II SC
TOKUYAMA AMERICA, INC. 510(k) NO: K991711(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET NW SE DECISION MADE: 07-JUL-99
SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
TRANSTRACHEAL SYSTEMS 510(k) NO: K982943(TRADITIONAL)
ATTN: LEWIS W WARD PHONE NO : 303-530-3279
4655 KIRKWOOD COURT SE DECISION MADE: 12-JUL-99
BOULDER, CO 80301 510(k) STATEMENT
DEVICE: ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
TREK DIAGNOSTICS SYSTEMS, INC. 510(k) NO: K972772(TRADITIONAL)
ATTN: NADINE SULLIVAN PHONE NO : 800-871-8909
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 13-JUL-99
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODE
TRIMEDYNE, INC. 510(k) NO: K992230(TRADITIONAL)
ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300
2801 BARRANCA RD. SE DECISION MADE: 12-JUL-99
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSE
TUTTNAUER USA CO. LTD. 510(k) NO: K990761(TRADITIONAL)
ATTN: MARK M YACURA PHONE NO : 202-887-4071
1333 NEW HAMPSHIRE AVE., N.W. SE DECISION MADE: 09-JUL-99
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
TYCO INTL. (US), INC. 510(k) NO: K992288(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE SE DECISION MADE: 30-JUL-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
UNITED PACIFIC CO., LTD. 510(k) NO: K991503(TRADITIONAL)
ATTN: DANIEL YE HUA PHONE NO : 626-458-8518
219 SOUTH RAYMOND AVE. SE DECISION MADE: 28-JUL-99
ALHAMBRA, CA 91801 510(k) STATEMENT
DEVICE: VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
VENTANA MEDICAL SYSTEMS INC. 510(k) NO: K990618(TRADITIONAL)
ATTN: JUDITH FREDERICK PHONE NO : 520-690-2731
3865 N. BUSINESS CENTER DR. SE DECISION MADE: 23-JUL-99
TUCSON, AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
VISTA MEDICAL TECHNOLOGIES, INC. 510(k) NO: K991303(TRADITIONAL)
ATTN: VICKI ANASTASI PHONE NO : 508-366-3668
134 FLANDERS RD. SE DECISION MADE: 12-JUL-99
WESTBOROUGH, MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPTFE RINGED GORE-TEX VASCULAR GRAFT
W.L. GORE & ASSOCIATES,INC 510(k) NO: K991602(TRADITIONAL)
ATTN: TIMOTHY J RYAN PHONE NO : 800-437-8181
3450 WEST KILTIE LANE SE DECISION MADE: 09-JUL-99
FLAGSTAFF,, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE-TEX DUALMESH BIOMATERIAL
W.L. GORE & ASSOCIATES,INC 510(k) NO: K992189(SPECIAL)
ATTN: R, LARRY PRATT PHONE NO : 520-779-2771
3750 WEST KILTIE LN. SE DECISION MADE: 29-JUL-99
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS MONITOR
WELCH ALLYN, INC. 510(k) NO: K984033(TRADITIONAL)
ATTN: ZORAN I PSENICNKI PHONE NO : 315-685-4400
4341 STATE STREET RD. SE DECISION MADE: 08-JUL-99
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP-WAVE 3000 (P07)
WOM GMBH 510(k) NO: K990732(TRADITIONAL)
ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188
194 BRANCH ST SE DECISION MADE: 23-JUL-99
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS DIODE LASER SYSTEM AND ACCESSORIES
XINTEC CORP. 510(k) NO: K990914(TRADITIONAL)
ATTN: MARILYN M CHOU PHONE NO : 510-832-2130
900 ALICE ST. SE DECISION MADE: 30-JUL-99
OAKLAND, CA 94607 510(k) STATEMENT
DEVICE: THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST
ZEUS SCIENTIFIC, INC. 510(k) NO: K984180(TRADITIONAL)
ATTN: MARK J KOPNITSKY PHONE NO : 908-526-3744
200 EVANS WAY SE DECISION MADE: 20-JUL-99
BRANCHBURG, NJ 08876 510(k) STATEMENT
DEVICE: TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
ZIMMER, INC. 510(k) NO: K990135(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
P.O. BOX 708 SE DECISION MADE: 12-JUL-99
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS);
ZIMMER, INC. 510(k) NO: K991581(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 219-372-4944
P.O. BOX 708 SE DECISION MADE: 30-JUL-99
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ZYMED HOLTER 2000
ZYMED MEDICAL INSTRUMENTATION 510(k) NO: K992197(SPECIAL)
ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941
20 NORTH AVIADOR STREET SE DECISION MADE: 28-JUL-99
CAMARILLO, CA 93010 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 281
TOTAL WITH SUMMARIES 209
TOTAL WITH STATEMENTS 72
Updated 3/11/2001
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