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Medical Devices
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June 2008 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUN-2008 THROUGH 30-JUN-2008
DEVICE: ERGO++ VERSION 1.7
3D LINE MEDICAL SYSTEMS S.R.L. 510(k) NO: K080601(TRADITIONAL)
ATTN: THOMAS VALENTINE PHONE NO : 770-670-2548
4775 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 06-JUN-08
BLDG 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON
4M VENTURES, INC. 510(k) NO: K080703(TRADITIONAL)
ATTN: DENICE GALLAGHER PHONE NO : 972-446-6611
1415 HALSEY WAY SE DECISION MADE: 02-JUN-08
SUITE 304 510(k) SUMMARY AVAILABLE FROM FDA
CARROLLTON, TX 75007-4455
DEVICE: FOXCROSS PTA CATHETER
ABBOTT VASCULAR INC. 510(k) NO: K081417(SPECIAL)
ATTN: NADINE SMITH PHONE NO : 951-914-2292
3200 LAKESIDE DRIVE SE DECISION MADE: 04-JUN-08
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCIN UNIPOLAR HEAD SYSTEM
ACCELERATED INNOVATION, LLC 510(k) NO: K080539(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832
1033 US HIGHWAY 46 EAST SE DECISION MADE: 02-JUN-08
SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA
CLIFTON, NJ 07013
DEVICE: CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION S
ACHEVE TECHNOLOGY, INC. 510(k) NO: K072861(TRADITIONAL)
ATTN: JIM-SON CHOU PHONE NO : 949-294-6458
17100 GILLETTE AVE., UNIT 113 SE DECISION MADE: 24-JUN-08
IRVIN, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATCHHALER
ACTIVAERO AMERICA, INC. 510(k) NO: K080100(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 30-JUN-08
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
ADROIT MEDICAL SYSTEMS, INC. 510(k) NO: K073712(TRADITIONAL)
ATTN: JON R HERMANSON PHONE NO : 865-458-8600
1146 CARDING MACHINE RD. SE DECISION MADE: 06-JUN-08
LOUDON, TN 37774 510(k) STATEMENT
DEVICE: METHA HIP SYSTEM
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K071916(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PKWY. SE DECISION MADE: 02-JUN-08
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO
AESCULIGHT, LLC 510(k) NO: K081612(TRADITIONAL)
ATTN: PAUL DIAZ PHONE NO : 425-483-8905
16928 WOOD-RED ROAD N.E. SE DECISION MADE: 25-JUN-08
SUITE B104 510(k) SUMMARY AVAILABLE FROM FDA
WOODINVILLE, WA 98072
DEVICE: MACS CPAP SYSTEM
AIRON CORPORATION 510(k) NO: K080692(TRADITIONAL)
ATTN: ERIC GJERDE PHONE NO : 321-821-9433
129 W. HIBISCUS BLVD., SUITE S SE DECISION MADE: 20-JUN-08
MELBOURNE, FL 32901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072140(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072141(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072142(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DRIVE SE DECISION MADE: 26-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-TEST CA
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K072356(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DRIVE SE DECISION MADE: 24-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-TEST C02
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K073223(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DRIVE SE DECISION MADE: 26-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-TEST CREATININE (CRE)
ALFA WASSERMANN, INC. 510(k) NO: K080073(TRADITIONAL)
ATTN: DAVID SLAVIN PHONE NO : 973-852-0158
4 HENDERSON DR. SE DECISION MADE: 30-JUN-08
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940,
ALMA LASERS LTD. 510(k) NO: K072182(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE. SE DECISION MADE: 27-JUN-08
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR VISION NEO, DR VISION DOU
ALMANA MEDICAL IMAGING 510(k) NO: K080614(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 20-JUN-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALZ WEB PACS, VERSION 1.0
ALZ, INC. 510(k) NO: K081304(TRADITIONAL)
ATTN: CYNTHIA NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 11-JUN-08
NORTH ATTLEBORO, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY GLUCOSE MANAGEMENT SYSTEM
ANIMAS CORP. 510(k) NO: K080639(TRADITIONAL)
ATTN: AMY SMITH PHONE NO : 484-568-1257
200 LAWRENCE DR. SE DECISION MADE: 24-JUN-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO-TOUCH NITRAFREE
ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K080536(TRADITIONAL)
ATTN: LON D MCIIVAIN PHONE NO : 334-615-2562
1635 INDUSTRIAL RD. SE DECISION MADE: 19-JUN-08
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOMAD PRO X-RAY SYSTEM
ARIBEX, INC. 510(k) NO: K081664(TRADITIONAL)
ATTN: D. CLARK TURNER PHONE NO : 801-226-5522
744 SOUTH 400 EAST SE DECISION MADE: 23-JUN-08
OREM, UT 84651 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GLUCCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEMS
ARKRAY FACTORY USA, INC. 510(k) NO: K073416(TRADITIONAL)
ATTN: TOM SPEIKERS PHONE NO : 952-646-3168
5182 WEST 76TH ST. SE DECISION MADE: 13-JUN-08
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE INJFECTABLE PICC
ARROW INTERNATIONAL, INC. 510(k) NO: K080604(TRADITIONAL)
ATTN: JULIE LAWSON PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 27-JUN-08
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION PYROCARBON LUNATE
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K080997(TRADITIONAL)
ATTN: DEBBIE STEARNS PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 17-JUN-08
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
AVITA CORPORATION 510(k) NO: K081160(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
2904 N. BOLDT DR. SE DECISION MADE: 24-JUN-08
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRO
AXELGAARD MFG. CO., LTD. 510(k) NO: K080580(TRADITIONAL)
ATTN: DAN P JEFFERY PHONE NO : 760-451-8000
520 INDUSTRIAL WAY SE DECISION MADE: 18-JUN-08
FALLBROOK, CA 92028-2244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTOSAN WOUND IRRIGATION SOLUTION
B. BRAUN MEDICAL, INC. 510(k) NO: K072876(TRADITIONAL)
ATTN: REBECCA STOLARICK PHONE NO : 610-596-2536
901 MARCON BLVD. SE DECISION MADE: 19-JUN-08
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED
BAUSCH & LOMB, INC. 510(k) NO: K080755(TRADITIONAL)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 10-JUN-08
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCCULT ICT
BECKMAN COULTER, INC. 510(k) NO: K080812(TRADITIONAL)
ATTN: SYLVIA ZORICH PHONE NO : 650-845-3453
200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 25-JUN-08
PO BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822
DEVICE: MRSASELECT - EXTENDED INCUBATION
BIO-RAD 510(k) NO: K081212(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 13-JUN-08
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLATELIA LYME IGM
BIO-RAD 510(k) NO: K081362(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 26-JUN-08
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
BIOCOMPOSITES LTD. 510(k) NO: K081428(SPECIAL)
ATTN: SIMON FITZER PHONE NO : 44 178 2338580
KEELE SCIENCE PARK SE DECISION MADE: 20-JUN-08
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATERLASE, VERSION 3.0
BIOLASE TECHNOLOGY, INC. 510(k) NO: K081589(SPECIAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144
4 CROMWELL SE DECISION MADE: 13-JUN-08
IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUCLISENS EASYQ ENTEROVIRUS SYSTEM
BIOMERIEUX, INC. 510(k) NO: K063261(TRADITIONAL)
ATTN: SANDRA PERREAND PHONE NO : 919-620-2000
100 RODOLPHE ST SE DECISION MADE: 23-JUN-08
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
BIOMERIEUX, INC. 510(k) NO: K080931(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM RD. SE DECISION MADE: 11-JUN-08
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
BIOMET MANUFACTURING, INC. 510(k) NO: K080088(TRADITIONAL)
ATTN: ROBERT R FRIDDLE PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 11-JUN-08
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: E-POLY TIBIAL BEARINGS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K080528(TRADITIONAL)
ATTN: MELISSA STEINWEDEL PHONE NO : 574-372-3970
56 EAST BELL DR. SE DECISION MADE: 17-JUN-08
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
BIOMET SPINE 510(k) NO: K081395(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300
100 INTERPACE PARKWAY SE DECISION MADE: 25-JUN-08
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET PHOENIX ANKLE NAIL SYSTEM
BIOMET TRAUMA 510(k) NO: K081243(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 27-JUN-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES
BIOMET, INC. 510(k) NO: K080330(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 11-JUN-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN
BIORETEC LTD 510(k) NO: K080879(TRADITIONAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 320 7789500
HERMIAKATU 22 MODULIGHT BLDG SE DECISION MADE: 24-JUN-08
TAMPERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CAN
BIORETEC LTD 510(k) NO: K081392(SPECIAL)
ATTN: MARI RUOTSALAINEN PHONE NO : 358 20 7789500
HERMIANKATU 22 MODULIGHT BLDG SE DECISION MADE: 18-JUN-08
TAMPERE, FINLAND FI-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
BIOSITE INCORPORATED 510(k) NO: K080269(TRADITIONAL)
ATTN: DAWN A ALLENBY PHONE NO : 858-805-2154
9975 SUMMERS RIDGE RD SE DECISION MADE: 06-JUN-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVX SPINE SYSTEM
BK MEDITECH CO., LTD. 510(k) NO: K080876(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
PO BOX 560 SE DECISION MADE: 04-JUN-08
STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAMENT BONE VOID FILLER, MODEL A0210
BONESUPPORT AB 510(k) NO: K073316(TRADITIONAL)
ATTN: ANN-CHRISTINE PROVOOST PHONE NO : 464 628 65370
SCHEELEVAGEN 19A SE DECISION MADE: 20-JUN-08
IDEON SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
LUND, SWEDEN SE 223-70
DEVICE: UNI-KNEE 2.0
BRAINLAB AG 510(k) NO: K080678(TRADITIONAL)
ATTN: PER PERSSON PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 06-JUN-08
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN RT IMAGE
BRAINLAB AG 510(k) NO: K080886(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 24-JUN-08
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEIFICATION TO IPLAN RT DOSE
BRAINLAB AG 510(k) NO: K080888(SPECIAL)
ATTN: CARSTEN RAUPACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 11-JUN-08
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD DIGNICARE STOOL MANAGEMENT SYSTEM
C.R. BARD, INC. 510(k) NO: K073598(TRADITIONAL)
ATTN: MICHELLE GUDITH PHONE NO : 770-784-6722
8195 INDUSTRIAL BLVD. SE DECISION MADE: 13-JUN-08
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
C.R. BARD, INC. 510(k) NO: K081311(SPECIAL)
ATTN: JIHYUN KIM PHONE NO : 801-595-0700
605 NORTH 5600 WEST SE DECISION MADE: 04-JUN-08
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: SPIRIT
CAIRE, INC. 510(k) NO: K080023(SPECIAL)
ATTN: ZULFIQAR A CHOUDARY PHONE NO : 770-425-4470
1800 SANDY PLAINS INDUSTRIAL SE DECISION MADE: 16-JUN-08
PARKWAY, STE.316 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30066
DEVICE: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
CANDELA CORP. 510(k) NO: K081324(SPECIAL)
ATTN: LISA LACROIX PHONE NO : 508-358-7400
530 BOSTON POST ROAD SE DECISION MADE: 17-JUN-08
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-60G
CANON, INC. 510(k) NO: K081648(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 24-JUN-08
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MRI PATIENT POSITIONING DEVICES
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K080072(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 04-JUN-08
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2,
CLINIQA CORPORATION 510(k) NO: K080973(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
774 N. TWIN OAKS VALLEY RD. SE DECISION MADE: 02-JUN-08
SAN MARCOS, CA 92069 510(k) STATEMENT
DEVICE: MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
CMA MICRODIALYSIS AB 510(k) NO: K071984(TRADITIONAL)
ATTN: NANCY BLANCO PHONE NO : 978-251-1940
73 PRINCETON STREET SE DECISION MADE: 27-JUN-08
NORTH CHELMSFORD, MA 01863 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTAPEK VBR SYSTEM
CO-LIGNE AG 510(k) NO: K072326(TRADITIONAL)
ATTN: DAVID SCHLERF PHONE NO : 925-356-2640
1070 CONRAD AVENUE, SUITE 230 SE DECISION MADE: 24-JUN-08
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCI RETRIEVER
CONCENTRIC MEDICAL, INC. 510(k) NO: K081305(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-938-2100
301 E. EVELYN AVE. SE DECISION MADE: 05-JUN-08
MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAMER ARGON SNARE PROBE
CONMED CORPORATION 510(k) NO: K081580(TRADITIONAL)
ATTN: KAREN PROVENCHER PHONE NO : 978-964-4232
129 CONCORD RD. SE DECISION MADE: 19-JUN-08
BLDG. #3 510(k) SUMMARY AVAILABLE FROM FDA
BILLERICA, MA 01821 THIRD PARTY REVIEW
DEVICE: CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
CONMED CORPORATION 510(k) NO: K081634(TRADITIONAL)
ATTN: SHAWN RIEDEL PHONE NO : 303-269-8224
14603 E. FREMONT AVE. SE DECISION MADE: 25-JUN-08
CENTENNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CABS'AIR
COUSIN BIOTECH S.A.S. 510(k) NO: K072962(TRADITIONAL)
ATTN: STEPHEN PLOQUIN PHONE NO : 33 03 20144000
8 RUE DE L'ABBE BONPAIN SE DECISION MADE: 26-JUN-08
WERVICQ-SUD, FRANCE 59117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTEN
CREASPINE 510(k) NO: K081564(SPECIAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207
49 PLAIN ST. SE DECISION MADE: 30-JUN-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K081049(SPECIAL)
ATTN: FRED MILDER PHONE NO : 505-955-8936
52 WEST BASIN RIDGE SE DECISION MADE: 27-JUN-08
GALISTEO, NM 87540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURE CATHETER CLOSED SYSTEM
CURE MEDICAL LLC. 510(k) NO: K080881(TRADITIONAL)
ATTN: JAMES SMITH PHONE NO : 949-340-7261
29442 POINTE ROYAL SE DECISION MADE: 11-JUN-08
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454,
DADE BEHRING, INC. 510(k) NO: K071597(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 04-JUN-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K071603(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
GLASGOW SITE, PO BOX 6101 SE DECISION MADE: 25-JUN-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K080175(ABBREVIATED)
ATTN: KATHLEEN KRAMER PHONE NO : 201-995-8169
800 MACARTHUR BLVD. SE DECISION MADE: 09-JUN-08
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081620(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 30-JUN-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUNTAINEER OCT SPINAL SYSTEM
DEPUY SPINE, INC. 510(k) NO: K080828(SPECIAL)
ATTN: LISA GILMAN PHONE NO : 508-880-8287
325 PARAMOUNT DR. SE DECISION MADE: 27-JUN-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILV
DERMA SCIENCES CANADA, INC. 510(k) NO: K080497(TRADITIONAL)
ATTN: SHARMINI ATHERAY PHONE NO : 416 299 4003
104 SHORTING RD. SE DECISION MADE: 27-JUN-08
TORONTO, ONTARIO, CANADA M1S 3S4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
DERMA SCIENCES, INC. 510(k) NO: K081584(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 19-JUN-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KI
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K081164(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-589-3300
1055 EAST STATE STREET SE DECISION MADE: 13-JUN-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ATHENS, OH 45701
DEVICE: ENDSNOR
DOCKSTADER ORTHODONTIC LAB, INC. 510(k) NO: K072731(ABBREVIATED)
ATTN: MICHAEL C BAUSMAN PHONE NO : 559-439-5160
340 WEST CROMWELL SE DECISION MADE: 12-JUN-08
FRESNO, CA 93711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K080959(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204
1155 ROBERTS BLVD. SE DECISION MADE: 27-JUN-08
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
DUCKWORTH & KENT, LTD. 510(k) NO: K072985(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254
7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 20-JUN-08
ROYSTON RD. 510(k) SUMMARY AVAILABLE FROM FDA
BALDOCK, HERTSFORDSHIRE, UNITED KINGDOM SG7 6XL
DEVICE: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
EKOS CORP. 510(k) NO: K081467(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132
11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 26-JUN-08
BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESKTOP PRO
ELEKTA LTD. 510(k) NO: K080585(TRADITIONAL)
ATTN: PATRICK T.M. HULL PHONE NO : 441 293 544422
LINAC HOUSE SE DECISION MADE: 11-JUN-08
FLEMING WAY, CRAWLEY 510(k) SUMMARY AVAILABLE FROM FDA
WEST SUSSEX, UNITED KINGDOM RH10 9RR
DEVICE: ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K073644(TRADITIONAL)
ATTN: KEN PERINO PHONE NO : 425-307-9200
8210 154TH AVE. NE SE DECISION MADE: 27-JUN-08
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
ENTELLUS MEDICAL, INC. 510(k) NO: K081542(SPECIAL)
ATTN: SEW-WAH TAY PHONE NO : 612-801-6782
18555 37TH AVENUE NORTH SE DECISION MADE: 27-JUN-08
PLYMOUTH, MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRKONDENT
ERGOMETA 510(k) NO: K080146(TRADITIONAL)
ATTN: MIKE ARTEMOV PHONE NO : 949-296-5375
144 LOS FLORES SE DECISION MADE: 06-JUN-08
ALISO VIEJO, CA 92656 510(k) STATEMENT
DEVICE: ETHICON ENDO SURGERY ARTICULATING SNARE
ETHICON ENDO-SURGERY, INC. 510(k) NO: K073288(TRADITIONAL)
ATTN: GLENDA C MARSH PHONE NO : 513-337-7659
4545 CREEK RD. SE DECISION MADE: 12-JUN-08
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
ETHICON ENDO-SURGERY, LLC 510(k) NO: K081146(TRADITIONAL)
ATTN: ABHILASHA MUKHERJEE PHONE NO : 513-337-3623
4545 CREEK ROAD SE DECISION MADE: 26-JUN-08
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FALCK APPLANATION TONOMETER (FAT2)
FALCK MEDICAL INC. 510(k) NO: K071755(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE RD.,SUITE 30 SE DECISION MADE: 03-JUN-08
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEEL-FINE INSULIN PEN NEEDLE
FEEL TECH 510(k) NO: K080904(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 04-JUN-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSER LP SYSTEM
FLOWCARDIA, INC. 510(k) NO: K080765(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408-617-0352
745 N. PASTORIA AVE. SE DECISION MADE: 20-JUN-08
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WG-SURGICAL SUTURES WITH NEEDLE
FOOSIN MEDICAL SUPPLIES INC. 510(k) NO: K080684(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467
SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 09-JUN-08
MANSION, NO. 19 LANE 999 510(k) SUMMARY AVAILABLE FROM FDA
ZHONG SHAN, SHANGHAI, CHINA 20030
DEVICE: FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
FREEDOM SCIENCES, LLC 510(k) NO: K073330(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-546-9810
5905 FAWN LANE SE DECISION MADE: 20-JUN-08
CLEVELAND, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM FCR VIEW, MODEL CR-VW674
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K081308(SPECIAL)
ATTN: DEBRA A PEACOCK PHONE NO : 203-602-3774
419 WEST AVE. SE DECISION MADE: 04-JUN-08
STAMFORD, CT 06902-6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HE4 EIA, MODEL: 404-10 US
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K072939(TRADITIONAL)
ATTN: DIANA L DICKSON PHONE NO : 610-240-3917
201 GREAT VALLEY PKWY. SE DECISION MADE: 09-JUN-08
MALVERN, PA 19355-1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GPS, G SURGICAL PEDICLE SYSTEM
G SURGICAL CO., LTD. 510(k) NO: K081041(TRADITIONAL)
ATTN: DONALD GRAFTON PHONE NO : 660 263 66842
152 SOI RAMKHAMHAENG 138 SE DECISION MADE: 27-JUN-08
SAPANSUNG 510(k) SUMMARY AVAILABLE FROM FDA
BANGKOK, THAILAND 10240
DEVICE: PRISMAFLEX M150 SET
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K080519(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303-542-5045
14143 DENVER WEST PARKWAY SE DECISION MADE: 13-JUN-08
LAKEWOOD, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRADIA FORTE
GC AMERICA, INC. 510(k) NO: K080478(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042
3737 WEST 127TH ST. SE DECISION MADE: 05-JUN-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GC OPB-100
GC AMERICA, INC. 510(k) NO: K080724(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-926-3042
3737 WEST 127TH ST. SE DECISION MADE: 11-JUN-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: PRECISION 500D R&F X-RAY SYSTEM
GE HEALTHCARE 510(k) NO: K081091(TRADITIONAL)
ATTN: MICHAEL PETROWSKI PHONE NO : 262-548-2673
3000 N GRANDVIEW BLVD. SE DECISION MADE: 11-JUN-08
W-709 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188
DEVICE: APEXPRO TELEMETRY SYSTEMS
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K080251(TRADITIONAL)
ATTN: BERNARD SANDLER PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 20-JUN-08
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY XR AND XA DIAGNOSTIC IMAGING SYSTEMS
GE MEDICAL SYSTEMS, LLC 510(k) NO: K081496(TRADITIONAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029
3000 N GRANDVIEW BLVD. SE DECISION MADE: 12-JUN-08
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACCELA SYSTEM
GENESIS BIOSYSTEMS, INC. 510(k) NO: K081578(TRADITIONAL)
ATTN: STEPHEN J MACDONALD PHONE NO : 972-315-7888
1500 EAGLE COURT SE DECISION MADE: 20-JUN-08
LEWISVILLE, TX 75057 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO GALILEO GOLD
HAMILTON MEDICAL AG 510(k) NO: K080181(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 81 6606010
VIA CRUSCH 8 SE DECISION MADE: 24-JUN-08
BONADUZ, SWITZERLAND CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSEI CATHETER CONTROL SYSTEM
HANSEN MEDICAL, INC. 510(k) NO: K073225(TRADITIONAL)
ATTN: DOUG WORTH PHONE NO : 650-404-5800
380 NORTH BERNARDO AVE. SE DECISION MADE: 30-JUN-08
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIMESH
HERNIAMESH S.R.L. 510(k) NO: K081327(TRADITIONAL)
ATTN: LORENA TRABUCCO PHONE NO : 516-987-9364
8 ORANGE DR. SE DECISION MADE: 19-JUN-08
JERICHO, NY 11753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K081198(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 18-JUN-08
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REJUVENATE MODULAR HIP SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K081044(SPECIAL)
ATTN: DENISE DAUGERT PHONE NO : 201-831-5413
325 CORPORATE DR. SE DECISION MADE: 03-JUN-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 FEMORAL NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K081152(SPECIAL)
ATTN: DANIELLE HILLMAN PHONE NO : 201-831-6365
325 CORPORATE DRIVE SE DECISION MADE: 10-JUN-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONNEXX LOCKING TIBIA NAIL
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K080706(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 09-JUN-08
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZURA TEE SYSTEM
IMACOR LLC 510(k) NO: K080223(TRADITIONAL)
ATTN: STEVEN B DATLOF M.D., J.D. PHONE NO : 267-675-4613
1835 MARKET STREET SE DECISION MADE: 24-JUN-08
28TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19103
DEVICE: INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
INTACT MEDICAL CORPORATION 510(k) NO: K081057(TRADITIONAL)
ATTN: DOUGLAS MACARTHUR PHONE NO : 508-655-7820
ONE APPLE HILL SUITE 316 SE DECISION MADE: 17-JUN-08
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXTEC MLX LIGHT SOURCE
INTEGRA LUXTEC, INC. 510(k) NO: K081477(TRADITIONAL)
ATTN: RITA WADLEIGH PHONE NO : 508-835-9700
99 HARTWELL ST. SE DECISION MADE: 18-JUN-08
WEST BOYLSTON, MA 01583 510(k) STATEMENT
DEVICE: INTEL HEALTH GUIDE, MODEL: PHS6000
INTEL CORP. 510(k) NO: K080798(ABBREVIATED)
ATTN: TAE-WOONG KOO PHONE NO : 408-765-2060
1900 PRAIRIE CITY RD., FM7-197 SE DECISION MADE: 27-JUN-08
FOLSOM, CA 95630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIATOR TRANSPORT INCUBATOR
INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K081399(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512-873-0033
8508 CROSS PARK DR. SE DECISION MADE: 06-JUN-08
AUSTIN, TX 78754 510(k) STATEMENT
DEVICE: DC NEURO
INVIVO CORPORATION 510(k) NO: K081262(TRADITIONAL)
ATTN: THEODORE J REISKER PHONE NO : 262-524-1402
N27 W23676 PAUL RD. SE DECISION MADE: 17-JUN-08
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ECARD AND CCARD
IRHYTHM TECHNOLOGIES, INC. 510(k) NO: K081471(TRADITIONAL)
ATTN: WILLIAM H RIGHTER PHONE NO : 415-252-1400
650 TOWNSEND STREET SE DECISION MADE: 24-JUN-08
SAN FRANCISCO, CA 94103 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: WATCH-PAT 200I (WP200I)
ITAMAR MEDICAL 510(k) NO: K081037(SPECIAL)
ATTN: JOHATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 09-JUN-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
IVU IMAGING CORPORATION 510(k) NO: K080555(TRADITIONAL)
ATTN: MARK L STRIBLING PHONE NO : 817-545-9766
4121 GRACE LANE SE DECISION MADE: 03-JUN-08
GRAPEVINE, TX 76051 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K2M, INC. 510(k) NO: K081381(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 13-JUN-08
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
KALTENBACH & VOIGT GMBH & CO. 510(k) NO: K080677(TRADITIONAL)
ATTN: CLAUDIA ORTIZ PHONE NO : 714-516-7981
1717 WEST COLLINS SE DECISION MADE: 06-JUN-08
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
KIMBERLY-CLARK CORP. 510(k) NO: K081027(ABBREVIATED)
ATTN: RICHARD W WOLFE PHONE NO : 770-587-8208
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 30-JUN-08
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L-VARLOCK
KISCOMEDICA S.A. 510(k) NO: K080537(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 30-JUN-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K080523(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800
12554 WEST BRIDGER ST. SE DECISION MADE: 17-JUN-08
SUITE 108 510(k) STATEMENT
BOISE, ID 83713
DEVICE: KYMCO FORU, MODEL EQ40
KWANG YANG MOTOR CO., LTD. 510(k) NO: K081133(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 10-JUN-08
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCU
LAZARUS MEDICAL LLC 510(k) NO: K073702(TRADITIONAL)
ATTN: CYNTHIA J.M NOLTE PHONE NO : 919-859-4207
2129 BENEVENTUM CT SE DECISION MADE: 26-JUN-08
RALEIGH, NC 27606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY
LEVITRONIX LLC. 510(k) NO: K081221(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781-622-5075
45 FIRST AVE. SE DECISION MADE: 19-JUN-08
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
LIFESCAN, INC. 510(k) NO: K081318(SPECIAL)
ATTN: FRANK PERALTA PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 09-JUN-08
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS S
LORENZ BIOTECH S.P.A. 510(k) NO: K080902(ABBREVIATED)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 13-JUN-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTAG RESPIRATORY VIRAL PANEL
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K081483(SPECIAL)
ATTN: GLORIA LEE PHONE NO : 416 593 4323
439 UNIVERSITY AVE. SE DECISION MADE: 25-JUN-08
TORONTO, ONTARIO, CANADA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIC LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K080932(SPECIAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 09-JUN-08
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWC/DWC WARMING CABINETS
MAC MEDICAL 510(k) NO: K080609(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 13-JUN-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
MAKO SURGICAL CORP. 510(k) NO: K080368(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2555 DAVIE RD., SUITE 110 SE DECISION MADE: 20-JUN-08
FT. LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION,
MAQUET CRITICAL CARE AB 510(k) NO: K073179(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-947-2311
1140 ROUTE 22 EAST SE DECISION MADE: 09-JUN-08
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
BRIDGEWATER, NJ 08807
DEVICE: MARTIN CHAIR, MODEL C4S1
MARTIN MANUFACTURING CO., LLC 510(k) NO: K080506(ABBREVIATED)
ATTN: MICHAEL ZAPATA, III PHONE NO : 919-696-7814
621-101 HUTTON ST SE DECISION MADE: 09-JUN-08
RALEIGH, NC 27606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT CABLE
MED-DYNE 510(k) NO: K080112(TRADITIONAL)
ATTN: E.W. JOHNSON PHONE NO : 502-429-4140
2775 SOUTH FLOYD ST. SE DECISION MADE: 20-JUN-08
LOUISVILLE, KY 40209 510(k) STATEMENT
DEVICE: NEB-90 LARGE VOLUME MEDICATION NEBULIZER
MEDI NUCLEAR CORP., INC. 510(k) NO: K080657(TRADITIONAL)
ATTN: MICHAEL MCPECK PHONE NO : 800-321-5981
4610 LITTLEJOHN ST. SE DECISION MADE: 30-JUN-08
BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERO, VERSION 2.0
MEDICAL PREDICTIVE SCIENCE CORP. 510(k) NO: K081473(SPECIAL)
ATTN: WILLIAM E KING PHONE NO : 434-220-0714
2246 IVY RD., SUITE 17 SE DECISION MADE: 27-JUN-08
CHARLOTTESVILLE, VA 22903 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
MEDPRO SAFETY PRODUCTS, INC. 510(k) NO: K072602(ABBREVIATED)
ATTN: GREG E MITCHELL PHONE NO : 859-244-7548
250 WEST MAIN STREET SE DECISION MADE: 18-JUN-08
SUITE 2700 510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, KY 40507-1749
DEVICE: MEDRAD INTEGO PET INFUSION SYSTEM
MEDRAD, INC. 510(k) NO: K080297(TRADITIONAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 17-JUN-08
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K081297(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 11-JUN-08
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIS FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K062254(TRADITIONAL)
ATTN: EDWARD CHIN PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 16-JUN-08
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC EXPORT AP CATHETER
MEDTRONIC VASCULAR 510(k) NO: K081573(SPECIAL)
ATTN: TARA N TURNEY PHONE NO : 978-739-6654
37A CHERRY HILL DRIVE SE DECISION MADE: 27-JUN-08
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
MEDXPERT GMBH 510(k) NO: K073556(TRADITIONAL)
ATTN: FRANZ MENEAN PHONE NO : 049 746 3995411
GRIESWEG 47 SE DECISION MADE: 24-JUN-08
MUHLHEIM, BADEN-WURTTEMBERG, GERMA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON XVU
MENNEN MEDICAL LTD. 510(k) NO: K081484(SPECIAL)
ATTN: IFAT OREN PHONE NO : 972 893 23333
4 HAYARDEN ST., YAVNE SE DECISION MADE: 20-JUN-08
P.O.BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: BONEMEDIK-DM
META BIOMED CO., LTD. 510(k) NO: K080772(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 834 221 81983
414-21 MO CHOONG DONG, SE DECISION MADE: 03-JUN-08
CHONG JU CITY 510(k) SUMMARY AVAILABLE FROM FDA
REPUBLIC OF KOREA, REPUBLIC OF KOREA
DEVICE: MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K080379(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 30-JUN-08
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
MINOS MEDICAL 510(k) NO: K080550(TRADITIONAL)
ATTN: TOM COLONNA PHONE NO : 949-215-1835
15560-C ROCKFIELD BLVD SE DECISION MADE: 10-JUN-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATURN 9000-810
NEW MEDICAL CO., LTD. 510(k) NO: K080589(SPECIAL)
ATTN: YOUNG-HOON SHIN PHONE NO : 886 287 916268
4F, NO.42, SINGZHONG RD. SE DECISION MADE: 11-JUN-08
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
NEW STAR LASERS, INC. 510(k) NO: K081628(SPECIAL)
ATTN: NATALIE R VOLLRATH PHONE NO : 916-677-1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 20-JUN-08
ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENIUM II
NEXT MOBILITY, LLC 510(k) NO: K081665(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 27-JUN-08
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NILIMEDIX ADI
NILIMEDIX LTD. 510(k) NO: K070844(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837
31 HAAVODA ST. SE DECISION MADE: 06-JUN-08
BINYAMINA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGER PULSE OXIMETER, MODEL 9560
NONIN MEDICAL, INC. 510(k) NO: K081285(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 05-JUN-08
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
OLYMPIC MEDICAL CORP. 510(k) NO: K081094(SPECIAL)
ATTN: STEVE HESLER PHONE NO : 206-767-3500
5900 FIRST AVE., SOUTH SE DECISION MADE: 20-JUN-08
SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
OPTICAL IMAGING LTD. 510(k) NO: K080180(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. NW SE DECISION MADE: 11-JUN-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
ORQIS MEDICAL CORPORATION 510(k) NO: K073631(TRADITIONAL)
ATTN: RYAN KELLY PHONE NO : 949-707-5890
14 ORCHARD ROAD, SUITE 100 SE DECISION MADE: 27-JUN-08
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS C
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K081411(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 30-JUN-08
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
ORTHOPEDIATRICS, LLC 510(k) NO: K081097(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 NORTH BUFFALO STREET SE DECISION MADE: 03-JUN-08
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
ORTHOVITA, INC. 510(k) NO: K081439(SPECIAL)
ATTN: DAVID J MCILHENNY PHONE NO : 610-407-5211
45 GREAT VALLEY PKWY. SE DECISION MADE: 17-JUN-08
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCLUSION BALLOON CATHETER, MODEL VENOS
OSCOR INC. 510(k) NO: K081052(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 18-JUN-08
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K080675(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586
KARL-HALL-STRASSE 01 SE DECISION MADE: 20-JUN-08
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUX 1540 HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K080244(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2300
82 CAMBRIDGE ST. SE DECISION MADE: 20-JUN-08
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA SERIES HYPERBARIC CHAMBER
PERRY BAROMEDICAL CORP. 510(k) NO: K072427(ABBREVIATED)
ATTN: JOHN CROCKER PHONE NO : 561-840-0395
3660 INTERSTATE PKWY. SE DECISION MADE: 11-JUN-08
RIVIERA BEACH, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K081426(TRADITIONAL)
ATTN: MELINDA NOVATNY PHONE NO : 440-483-4255
595 MINER RD. SE DECISION MADE: 04-JUN-08
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HD15 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K081661(TRADITIONAL)
ATTN: PHONE NO :
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 24-JUN-08
BOTHELL, WA 98041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NERVE MONITORING CABLE
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K073229(ABBREVIATED)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 06-JUN-08
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
PLASMA SURGICAL, LTD. 510(k) NO: K080197(TRADITIONAL)
ATTN: PETER GIBSON PHONE NO : 44 118 9166790
BRUNEL ROAD SE DECISION MADE: 24-JUN-08
THEALE, BERKSHIRE, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
POSSIS MEDICAL, INC. 510(k) NO: K081454(SPECIAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 13-JUN-08
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
PRECISION SURGERY LTD. 510(k) NO: K073708(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 03-JUN-08
CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
PROCTER & GAMBLE CO. 510(k) NO: K081555(SPECIAL)
ATTN: LENORE FAULHABER PHONE NO : 513-634-2466
6110 CENTER HILL AVE. SE DECISION MADE: 27-JUN-08
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
QUEST DIAGNOSTICS, INC. 510(k) NO: K080381(TRADITIONAL)
ATTN: LIUMING YU PHONE NO : 913-895-2308
10101 RENNER BLVD. SE DECISION MADE: 25-JUN-08
LENEXA, KS 66219-9752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAMIN AIR
REMGENIC LLC 510(k) NO: K080516(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 23-JUN-08
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY VCO2 MODULE WITH CAPNOSTAT 5
RESPIRONICS NOVAMETRIX LLC 510(k) NO: K080652(SPECIAL)
ATTN: KEVIN MADER PHONE NO : 203-697-6466
5 TECHNOLOGY DRIVE SE DECISION MADE: 20-JUN-08
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K080617(TRADITIONAL)
ATTN: NIELS SCHMIDT PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 27-JUN-08
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TR-USB TELEPHONIC STETHOSCOPE
RNK PRODUCTS, INC. 510(k) NO: K081032(TRADITIONAL)
ATTN: CHARLES R ABBRUSCATO PHONE NO : 612-414-0289
12700 DIAMOND DRIVE SE DECISION MADE: 06-JUN-08
BURNSVILLE, MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL T
ROCHE DIAGNOSTICS CORP. 510(k) NO: K073501(TRADITIONAL)
ATTN: THERESA A BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 09-JUN-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K080811(TRADITIONAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 20-JUN-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUTOPATCH, TUTOMESH
RTI BIOLOGICS, INC. 510(k) NO: K081538(SPECIAL)
ATTN: TRAVIS AROLA PHONE NO : 386-418-8888
11621 RESEARCH CIRCLE SE DECISION MADE: 19-JUN-08
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-1627
DEVICE: SMARTBURS
S.S. WHITE BURS, INC. 510(k) NO: K080687(TRADITIONAL)
ATTN: DEREK GLADDEN PHONE NO : 732-905-1100
1145 TOWBIN AVE. SE DECISION MADE: 20-JUN-08
LAKEWOOD, NJ 08701 510(k) STATEMENT
DEVICE: APOLLO MINI IPL SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K081219(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205-290-8251
102 OXMOOR RD. SE DECISION MADE: 30-JUN-08
SUITE 13 510(k) SUMMARY AVAILABLE FROM FDA
HOMEWOOD, AL 35209
DEVICE: SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
SECTRA IMTEC AB 510(k) NO: K081469(SPECIAL)
ATTN: CARL ALLETO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 12-JUN-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIGENT CREATININE (ENZYMATIC) ASSAY
SENTINEL CH. SPA 510(k) NO: K073634(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448
VIA ROBERT KOCH, 2 SE DECISION MADE: 19-JUN-08
MILANO, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENTINEL PLASMAPROTEINS CAL 3X
SENTINEL CH. SPA 510(k) NO: K081533(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448
VIA ROBERT KOCH, 2 SE DECISION MADE: 25-JUN-08
MILANO, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRI
SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K081322(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 18-JUN-08
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K081340(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 18-JUN-08
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SHARPS TRANSPORT TUBE, MODEL 50035
SHARPS COMPLIANCE, INC. 510(k) NO: K073577(TRADITIONAL)
ATTN: DAVID OLMSTEAD PHONE NO : 615-278-9292
614 HUNTERS LANE SE DECISION MADE: 23-JUN-08
BRENTWOOD, TN 37027 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K073280(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-JUN-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESICEM
SHOFU DENTAL CORP. 510(k) NO: K080517(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 11-JUN-08
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: VINTAGE ART
SHOFU DENTAL CORP. 510(k) NO: K080834(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 11-JUN-08
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K073537(TRADITIONAL)
ATTN: NOOR MALKI PHONE NO : 781-269-3401
2 EDGEWATER DR. SE DECISION MADE: 27-JUN-08
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM DEFINITION, MODEL AS/AS+
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081022(TRADITIONAL)
ATTN: CORRINE MCLEOD PHONE NO : 610-448-1772
51 VALLEY STREAM PKWY. SE DECISION MADE: 02-JUN-08
E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: BIOGRAPH HD FAMILY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081453(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703
810 INNOVATION DR. SE DECISION MADE: 23-JUN-08
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081121(TRADITIONAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434
1230 SHOREBIRD WAY SE DECISION MADE: 04-JUN-08
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K081332(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 10-JUN-08
CHSETERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-VOID, SPIDER
SINTEA BIOTECH, INC. 510(k) NO: K072198(TRADITIONAL)
ATTN: GUSTAVO A RIOS PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 06-JUN-08
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SL-PLUS STANDARD AND LATERAL HIP STEMS
SMITH & NEPHEW, INC. 510(k) NO: K072852(TRADITIONAL)
ATTN: NICHOLAS B TABRIZI PHONE NO : 901-399-6017
1450 BROOKS RD. SE DECISION MADE: 09-JUN-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS
SMITH & NEPHEW, INC. 510(k) NO: K081106(SPECIAL)
ATTN: LAURA SEJNOWSKI PHONE NO : 901-399-5349
1450 BROOKS RD. SE DECISION MADE: 18-JUN-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW CDS SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K081491(SPECIAL)
ATTN: MASON W ROBBINS PHONE NO : 901-399-6021
1450 E BROOKS ROAD SE DECISION MADE: 19-JUN-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFL
SMITHS MEDICAL ASD, INC. 510(k) NO: K072080(TRADITIONAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812
160 WEYMOUTH ST. SE DECISION MADE: 02-JUN-08
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
SSL AMERICAS, INC. 510(k) NO: K072169(ABBREVIATED)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2157
3585 ENGINEERING DR. SE DECISION MADE: 19-JUN-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: PROVEN STEM EXTENDER
STELKAST COMPANY 510(k) NO: K081458(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY RD. SE DECISION MADE: 06-JUN-08
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: BROWNE OPA TEST STRIP
STERIS CORPORATION 510(k) NO: K081427(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440-392-7695
5960 HEISLEY RD. SE DECISION MADE: 11-JUN-08
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-ACTOR VIBRATION MASSAGE SYSTEM
STORZ MEDICAL AG 510(k) NO: K072809(TRADITIONAL)
ATTN: MICHAEL DAYTON PHONE NO : 813-949-6090
4608 RUE BORDEAUX SE DECISION MADE: 27-JUN-08
LUTZ, FL 33558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THOR ANTERIOR PLATING SYSTEM
STRYKER SPINE 510(k) NO: K080773(TRADITIONAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296
2 PEARL COURT SE DECISION MADE: 09-JUN-08
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INREACH SYSTEM
SUPERDIMENSION, LTD. 510(k) NO: K081379(SPECIAL)
ATTN: JONATHAN KOVACH PHONE NO : 763-210-4015
161 CHESHIRE LANE NORTH, SE DECISION MADE: 11-JUN-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55441-5433
DEVICE: STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
SURGICRAFT LTD. 510(k) NO: K073109(ABBREVIATED)
ATTN: DONALD W GUTHNER PHONE NO : 646-460-2984
111 HILL ROAD SE DECISION MADE: 04-JUN-08
DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICRAFT SCREW FIXATION SYSTEM
SURGICRAFT LTD. 510(k) NO: K080447(TRADITIONAL)
ATTN: DONALD W GUTHNER PHONE NO : 888-614-9649
111 HILL ROAD SE DECISION MADE: 13-JUN-08
DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
SUTURES INDIA PVT., LTD. 510(k) NO: K081001(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000
472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08
PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
BANGALORE, INDIA 560058
DEVICE: MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
SUTURES INDIA PVT., LTD. 510(k) NO: K081002(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000
472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08
PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
BANGALORE, INDIA 560058
DEVICE: TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
SUTURES INDIA PVT., LTD. 510(k) NO: K081003(TRADITIONAL)
ATTN: L.G. CHANDRASEKHAR PHONE NO : 91 80 41868000
472 D, 13TH CROSS, 4TH PHASE SE DECISION MADE: 09-JUN-08
PEENYA INDUSTRIAL AREA 510(k) SUMMARY AVAILABLE FROM FDA
BANGALORE, INDIA 560058
DEVICE: CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORIN
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080014(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 09-JUN-08
WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTE
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080283(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 27-JUN-08
WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MOD
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081144(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 23-JUN-08
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
TEIKOKU PHARMA USA, INC. 510(k) NO: K072560(TRADITIONAL)
ATTN: MARGIE NEMCIK-CRUZ PHONE NO : 408-501-1880
1718 RINGWOOD AVE. SE DECISION MADE: 17-JUN-08
SAN JOSE, CA 95131-1711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEB-U-MASK SYSTEM, MODELS 1895, 1896
TELEFLEX MEDICAL, INC. 510(k) NO: K080230(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DR SE DECISION MADE: 09-JUN-08
BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K080034(TRADITIONAL)
ATTN: ANDREA WALLEN PHONE NO : 734-741-6395
6200 JACKSON RD. SE DECISION MADE: 17-JUN-08
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
THE BINDING SITE, LTD. 510(k) NO: K080384(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 06-JUN-08
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: MODIFICATION TO CORAL SPINAL SYSTEM
THEKEN SPINE LLC 510(k) NO: K081414(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600
1800 TRIPLETT BLVD. SE DECISION MADE: 17-JUN-08
AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITE WAND II
THOMPSON SURGICAL INSTRUMENTS, INC510(k) NO: K080962(TRADITIONAL)
ATTN: STEPHANIE A KALUCHA PHONE NO : 231-922-5170
10170 EAST CHERRY BEND ROAD SE DECISION MADE: 25-JUN-08
TRAVERSE CITY, MI 49684 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
TITAN SPINE, LLC 510(k) NO: K080615(TRADITIONAL)
ATTN: KEVIN GEMAS PHONE NO : 952-431-5999
10520 BAEHR RD SE DECISION MADE: 17-JUN-08
MEQUON, WI 53092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51
TOKOTU ELECTRIC CO., LTD. 510(k) NO: K081242(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO :
300 OYA, UEDA SE DECISION MADE: 11-JUN-08
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTELITE SIGMA QUICK
TOKUYAMA DENTAL CORPORATION 510(k) NO: K080940(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 19-JUN-08
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081065(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 06-JUN-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: CSBP-001A BODY ORGAN PERFUSION SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081482(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 11-JUN-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: INFX-8000V, INFINIX-CFI AND INFINIX VFI
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081582(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 17-JUN-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: INFX-8000C (INFINIX CC-I AND VC-I)
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081621(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 23-JUN-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: INFX-8000F (INFINIX CSI AND INFINIX DPI)
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K081624(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 23-JUN-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 21.3" (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
TOTOKU ELECTRIC CO., LTD. 510(k) NO: K081055(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA, UEDA SE DECISION MADE: 04-JUN-08
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21.3" (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
TOTOKU ELECTRIC CO., LTD. 510(k) NO: K081056(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA, UEDA SE DECISION MADE: 04-JUN-08
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUNDSTAT
TRAUMACURE INC. 510(k) NO: K081183(TRADITIONAL)
ATTN: CAMPBELL HUTTON PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVE. SE DECISION MADE: 19-JUN-08
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BL
TYSON BIORESEARCH, INC. 510(k) NO: K072854(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988
5 F., # 22, KE TUNG RD., SE DECISION MADE: 30-JUN-08
SCIENCE BASED INDUSTRIAL PARK 510(k) STATEMENT
CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350
DEVICE: ULTIMED ULTICARE SAFETY SYRINGE
ULTIMED, INC. 510(k) NO: K080600(TRADITIONAL)
ATTN: CAROLE STAMP PHONE NO : 952-746-8074
5353 WAYZATA BLVD. SE DECISION MADE: 25-JUN-08
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416-1334
DEVICE: ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
ULTIMED, INC. 510(k) NO: K081449(TRADITIONAL)
ATTN: C. STAMP PHONE NO : 952-746-8074
5353 WAYZATA BLVD. SE DECISION MADE: 03-JUN-08
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416-1334 THIRD PARTY REVIEW
DEVICE: PREFERENCE PEDICLE SCREW SYSTEM
US SPINE 510(k) NO: K081296(SPECIAL)
ATTN: RICHARD JANSEN, PHARM. D. PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 06-JUN-08
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USHIFU STEPPER
USHIFU DEVELOPMENT COMPANY, LLC 510(k) NO: K080970(TRADITIONAL)
ATTN: MARE RYAN PHONE NO : 386-785-0100
1450 SOUTH WOODLAND BLVD. SE DECISION MADE: 11-JUN-08
DELAND, FL 32720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
VELOCITY MEDICAL SOLUTIONS, LLC 510(k) NO: K081076(SPECIAL)
ATTN: PAUL SUMNER PHONE NO : 770-448-7529
1733 CANTON LANE SE DECISION MADE: 20-JUN-08
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K080673(TRADITIONAL)
ATTN: PHILIP B JARVI PHONE NO : 952-979-1804
14289 YELLOWPINE SE DECISION MADE: 10-JUN-08
ANDOVER, MN 55304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPLEY OMNIAX
VESTICON 510(k) NO: K071973(TRADITIONAL)
ATTN: CATHRYN EPLEY PHONE NO : 503-230-0539
2203 NE OREGON STREET SE DECISION MADE: 20-JUN-08
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
VIASYS HEALTHCARE GMBH 510(k) NO: K080734(TRADITIONAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383
LEIBNIZSTRASSE 7 SE DECISION MADE: 26-JUN-08
HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
VIASYS MEDSYSTEMS 510(k) NO: K080679(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 27-JUN-08
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: DRF 4343
VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K080859(TRADITIONAL)
ATTN: PAOLO C SANTIN PHONE NO : 39 024 88591
VIA DELLE AZALEE 3 SE DECISION MADE: 04-JUN-08
BUCCINASCO, ITALY 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPY VIDEO CAMERA SYSTEM
VISION SYSTEMS GROUP, A DIVISION O510(k) NO: K081585(SPECIAL)
ATTN: CHRISTINE E NICHOLS PHONE NO : 508-366-3668
10 GREENLAWN AVE SE DECISION MADE: 20-JUN-08
SOUTH GRAFTON, MA 01560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
VISUAL FOOTCARE TECHNOLOGIES, LLC 510(k) NO: K080816(TRADITIONAL)
ATTN: ANDREW SINGER PHONE NO : 866-385-6442
P.O. BOX 760 SE DECISION MADE: 24-JUN-08
SOUTH SALEM, NY 10590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
VITALOGRAPH(IRELAND) LTD. 510(k) NO: K073155(TRADITIONAL)
ATTN: TOM J HEALY PHONE NO : 35 365 6864100
ENNIS INDUSTRIAL ESTATE SE DECISION MADE: 04-JUN-08
GORT ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ENNIS, CO. CLARE, IRELAND
DEVICE: PRO TENS, MODEL WL-240 RX
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K080304(TRADITIONAL)
ATTN: JENNY HSIEH PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 SE DECISION MADE: 20-JUN-08
JUNGJENG RD. 510(k) SUMMARY AVAILABLE FROM FDA
YUNGHE CITY, TAIPEI COUNTY, CHINA (TAIWAN)
DEVICE: ZEN PROGRAM (MIND 440 HEARING AID)
WIDEX HEARING AID CO., INC. 510(k) NO: K080955(TRADITIONAL)
ATTN: FRANCIS KUK PHONE NO : 630-245-0025
2300 CABOT DRIVE SE DECISION MADE: 27-JUN-08
SUITE 415 510(k) SUMMARY AVAILABLE FROM FDA
LISLE, IL 60532
DEVICE: YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600,
YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K081590(TRADITIONAL)
ATTN: STEVEN CHANG PHONE NO : 02 879 71943
2F, NO. 13, HUANSHAN ROAD SE DECISION MADE: 19-JUN-08
LANE 28, SEC 1 510(k) SUMMARY AVAILABLE FROM FDA
NEI HU, TAIPEI, CHINA (TAIWAN) 114THIRD PARTY REVIEW
DEVICE: DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
ZEFON INTL. 510(k) NO: K080366(ABBREVIATED)
ATTN: SCOTT RYAN PHONE NO : 352-854-8080
5350 S.W. FIRST LN. SE DECISION MADE: 09-JUN-08
OCALA, FL 34474 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 243
TOTAL WITH SUMMARIES 222
TOTAL WITH STATEMENTS 21
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