SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-AUG-2006 THROUGH 31-AUG-2006
DEVICE: RELIEVA SINUS BALLOON CATHETER
ACCLARENT, INC. 510(k) NO: K061903(SPECIAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 18-AUG-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8M
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K061397(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL ST. SE DECISION MADE: 16-AUG-06
BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
ACMI CORPORATION 510(k) NO: K061975(SPECIAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739
136 TURNPIKE RD. SE DECISION MADE: 10-AUG-06
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON URINALYSIS REAGENT STRIPS
ACON LABORATORIES CO. 510(k) NO: K061559(TRADITIONAL)
ATTN: MARTIN O'CONNOR PHONE NO : 210-692-4192
4139 GARDENDALE CENTER SE DECISION MADE: 11-AUG-06
# 101 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78229
DEVICE: ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
ACRO BIOTECH LLC. 510(k) NO: K060355(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-322-4651
9500 7TH STREET UNIT M SE DECISION MADE: 07-AUG-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
ACTIVA TEK INC 510(k) NO: K061522(TRADITIONAL)
ATTN: DAVID SCOFIELD PHONE NO : 801-322-2002
340 BROADWAY CENTRE SE DECISION MADE: 01-AUG-06
111 EAST BROADWAY 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84111
DEVICE: ACUBAND ACUPRESSURE WRIST BAND DEVICE
ACUBAND INC. 510(k) NO: K053509(TRADITIONAL)
ATTN: RICHARD GRIFFITH PHONE NO : 732-219-9166
101 LITTLE SILVER POINT ROAD SE DECISION MADE: 16-AUG-06
LITTLE SILVER, NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
ACUMEN MEDICAL, INC. 510(k) NO: K062084(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 18-AUG-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-5
ACUMEN MEDICAL, INC. 510(k) NO: K062145(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 23-AUG-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO GAMMA CAMERA SYSTEM
ADAC LABORATORIES 510(k) NO: K062298(TRADITIONAL)
ATTN: ANNIE WRIGHT PHONE NO : 408-468-3779
540 ALDER DR. SE DECISION MADE: 23-AUG-06
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
AESCULAP, INC. 510(k) NO: K061344(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PKWY. SE DECISION MADE: 02-AUG-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCIA
AESCULAP, INC. 510(k) NO: K061699(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9274
3773 CORPORATE PKWY. SE DECISION MADE: 18-AUG-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
ALBERT BROWNE LTD. 510(k) NO: K061738(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 25-AUG-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDONE-BUPRENORPHINE TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K060760(TRADITIONAL)
ATTN: HENRY WELLS PHONE NO : 410-992-4734
9110 RED BRANCH ROAD SE DECISION MADE: 07-AUG-06
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21045
DEVICE: ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHI
ANGIODYNAMICS, INC. 510(k) NO: K061733(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 24-AUG-06
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K062169(TRADITIONAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 24-AUG-06
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARROW PRESSURE INJECTABLE PICC
ARROW INTERNATIONAL, INC. 510(k) NO: K061289(TRADITIONAL)
ATTN: ELIZABETH DUNCAN PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 24-AUG-06
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC SPINE SYSTEM
ARTHRO KINETICS INC. 510(k) NO: K061246(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 23-AUG-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
ARTHROTEK, INC. 510(k) NO: K061801(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 07-AUG-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K061451(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 11-AUG-06
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-808 ATOM TRANSCAPSULE
ATOM MEDICAL INC 510(k) NO: K061071(TRADITIONAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-672-6800
35 COMMERCE DRIVE SE DECISION MADE: 29-AUG-06
IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
AXIOM ORTHOPAEDICS, INC. 510(k) NO: K061862(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 28-AUG-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K061383(TRADITIONAL)
ATTN: LEYRE Z HERNANDO PHONE NO : 349 452 97030
PARQUE TECNOLOGICO DE ALAVA SE DECISION MADE: 03-AUG-06
LEONARDO DA VINCI 14B 510(k) SUMMARY AVAILABLE FROM FDA
MINANO(ALAVA), SPAIN 01510
DEVICE: CORONIS 2MP AND MDCG 2121 - CB
BARCOVIEW 510(k) NO: K061926(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 325 623 3459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 18-AUG-06
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO COAGULATION CATHETER
BARRX MEDICAL, INCORPORATED 510(k) NO: K062225(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 28-AUG-06
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 U
BECTON, DICKINSON & CO. 510(k) NO: K061867(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 10-AUG-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM
BECTON, DICKINSON & CO. 510(k) NO: K061869(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 18-AUG-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEST STRAND AND BEST SPACER
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K061638(TRADITIONAL)
ATTN: MICHAEL J PHELAN PHONE NO : 703-451-2378
7643 FULLERTON RD. SE DECISION MADE: 04-AUG-06
SPRINGFIELD, VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K061857(TRADITIONAL)
ATTN: JAMES JOCHEN ROGERS PHONE NO : 440-546-4936
P.O. BOX 470218 SE DECISION MADE: 01-AUG-06
BROADVIEW HEIGHTS, OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: QUADRATENS, MODEL QT-42
BIO-RESEARCH ASSOCIATES, INC. 510(k) NO: K061799(TRADITIONAL)
ATTN: JOHN C RADKE PHONE NO : 414-357-7525
9275 NORTH 49TH STREET SE DECISION MADE: 28-AUG-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
BROWN DEER, WI 53223
DEVICE: REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENT
BIOMET MANUFACTURING, INC. 510(k) NO: K053505(TRADITIONAL)
ATTN: TRACY B JOHNSON PHONE NO : 574-372-1644
56 EAST BELL DR. SE DECISION MADE: 14-AUG-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
BIOMET MANUFACTURING, INC. 510(k) NO: K061433(TRADITIONAL)
ATTN: TRACY BICKEL-JOHNSON PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 21-AUG-06
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOPRO MEMORY STAPLE
BIOPRO, INC. 510(k) NO: K061798(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 21-AUG-06
PORT HURON, MI 48060 510(k) STATEMENT
DEVICE: ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
BIOSENSE WEBSTER, INC. 510(k) NO: K061463(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 909-839-7272
3333 DIAMOND CANYON RD. SE DECISION MADE: 14-AUG-06
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFSTAR EXTERNAL REFERENCE PATCH
BIOSENSE WEBSTER, INC. 510(k) NO: K061468(SPECIAL)
ATTN: NATALIE BENNINGTON PHONE NO : 909-839-7272
3333 DIAMOND CANYON RD. SE DECISION MADE: 14-AUG-06
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
BIOSPHERE MEDICAL, INC. 510(k) NO: K062126(SPECIAL)
ATTN: IRINA KULINETS PHONE NO : 781-681-7916
1050 HINGHAM ST. SE DECISION MADE: 09-AUG-06
ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
BIOWAVE CORPORATION 510(k) NO: K061166(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 15-AUG-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
BLUE SKY MEDICAL GROUP INCORPORATE510(k) NO: K061367(TRADITIONAL)
ATTN: JASPER BENKE PHONE NO : 760-603-8130
5924 BALFOUR CT. SE DECISION MADE: 10-AUG-06
SUITE 102 510(k) STATEMENT
CARLSBAD, CA 92008
DEVICE: BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH
BONART CO. LTD. 510(k) NO: K061448(TRADITIONAL)
ATTN: ERIC L ONG PHONE NO : 909-594-8066
398 S. LEMON CREEK DR. SE DECISION MADE: 17-AUG-06
STE. L 510(k) STATEMENT
WALNUT, CA 91789
DEVICE: FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
BOSTON SCIENTIFIC CORP. 510(k) NO: K061332(SPECIAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 650-623-1600
2011 STIERLIN CT. SE DECISION MADE: 11-AUG-06
MOUNTAIN VIEW, CA 94043-4655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION HIP
BRAINLAB AG 510(k) NO: K060727(SPECIAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 21-AUG-06
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
BREAS MEDICAL AB 510(k) NO: K060657(SPECIAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 463 186 8800
FORETAGSVAGEN 1 SE DECISION MADE: 18-AUG-06
MOLNLYCKE, SWEDEN 435 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION
BURKE, INC. 510(k) NO: K061912(TRADITIONAL)
ATTN: DUWAYNE E KRAMER, JR. PHONE NO : 913-722-5658
1800 MERRIAM LN. SE DECISION MADE: 01-AUG-06
KANSAS CITY, KS 66106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
C.R. BARD, INC. 510(k) NO: K061179(TRADITIONAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 09-AUG-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYGAURD PAIN MANAGER INFUSION SYSTEM
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K061325(ABBREVIATED)
ATTN: SHLOMI DINES PHONE NO : 972 462 71737
16 SHACHAM STREET SE DECISION MADE: 24-AUG-06
CAESAREA INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CAESAREA, ISRAEL 38900
DEVICE: PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL
CAMBRIDGE ENDOSCOPIC DEVICES 510(k) NO: K061425(TRADITIONAL)
ATTN: LYNN BOUGIE PHONE NO : 508-597-1809
261 CEDAR HILL STREET SE DECISION MADE: 10-AUG-06
QUALITY AND REGULATORY AFFAIRS 510(k) SUMMARY AVAILABLE FROM FDA
MARLBOROUGH, MA 01752
DEVICE: CXDI-40EC
CANON, INC. 510(k) NO: K062221(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 17-AUG-06
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CG-6108 ARRHYTHMIA ECG EVENT RECORDER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K060911(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84000X4070
2 PEKERIS ST. SE DECISION MADE: 22-AUG-06
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
CARDIAC ASSIST, INC. 510(k) NO: K061369(SPECIAL)
ATTN: ROBERT BOLLINGER PHONE NO : 412-963-7770
240 ALPHA DR. SE DECISION MADE: 22-AUG-06
PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
CARDINAL HEALTH, INC. 510(k) NO: K061762(SPECIAL)
ATTN: LAVENIA FORD PHONE NO : 847-785-3323
1500 WAUKEGAN ROAD SE DECISION MADE: 01-AUG-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENHANCE DENTAL IMPLANT SYSTEM
COASTAL BIOCARE 510(k) NO: K061335(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 09-AUG-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: MARATHON STENT WITH FUSION TECHNOLOGY
COOK IRELAND LTD 510(k) NO: K060624(TRADITIONAL)
ATTN: EMMETT DEVEREUX PHONE NO : 353 613 34440
O'HOLLORAN ROAD SE DECISION MADE: 04-AUG-06
NATIONAL TECHNOLOGICAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
COOK UROLOGICAL, INC. 510(k) NO: K061371(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 17-AUG-06
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROQUANT
CORTECHS LABS, INC 510(k) NO: K061855(TRADITIONAL)
ATTN: ALLAN GREEN PHONE NO : 858-459-9700
1020 PROSPECT ST., SUITE 304 SE DECISION MADE: 10-AUG-06
LA JOLLA, CA 510(k) STATEMENT
DEVICE: RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
CREATIVE MEDICAL DESIGNS, INC. 510(k) NO: K061955(SPECIAL)
ATTN: JANE RAYHACK PHONE NO : 813-875-9999
13914 SHADY SHORES DR. SE DECISION MADE: 04-AUG-06
TAMPA, FL 33613 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOXX RAPID CLOTTING AGENT
CROSSLINK-D, INC 510(k) NO: K061722(TRADITIONAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-254-3565
150 ARAN HILL RD SE DECISION MADE: 02-AUG-06
FARFIELD, CT 06824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CO
CRYOCATH TECHNOLOGIES, INC. 510(k) NO: K062140(SPECIAL)
ATTN: FRED MILDER PHONE NO : 617-566-1915
204 CLINTON ROAD SE DECISION MADE: 24-AUG-06
BROOKLINE, MA 02445-5814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURATIVE DENTAL ACRYLIC TEETH
CURATIVE, LLC 510(k) NO: K060720(TRADITIONAL)
ATTN: JAMES R VEALE PHONE NO : 719-495-3438
49 PLAIN STREET SE DECISION MADE: 25-AUG-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX CDT
DADE BEHRING, INC. 510(k) NO: K060677(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 25-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
DADE BEHRING, INC. 510(k) NO: K061703(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 02-AUG-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA
DADE BEHRING, INC. 510(k) NO: K061719(TRADITIONAL)
ATTN: GEORGE W PLUMMER PHONE NO : 302-631-9798
P.O. BOX 6101 MS 514 SE DECISION MADE: 25-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
DADE BEHRING, INC. 510(k) NO: K061750(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
500 GBC DR, MAILSTOP 514 SE DECISION MADE: 11-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K061793(SPECIAL)
ATTN: ANDREA M TASKER PHONE NO : 302-631-9454
P.O. BOX 6101 MS 514 SE DECISION MADE: 07-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
DADE BEHRING, INC. 510(k) NO: K061838(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 21-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
DADE BEHRING, INC. 510(k) NO: K061839(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
P.O. BOX 6101 MS 514 SE DECISION MADE: 29-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRA
DADE BEHRING, INC. 510(k) NO: K061845(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 24-AUG-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL
DADE BEHRING, INC. 510(k) NO: K061872(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 23-AUG-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL
DADE BEHRING, INC. 510(k) NO: K061885(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 14-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
DADE BEHRING, INC. 510(k) NO: K061923(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 25-AUG-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIU
DADE BEHRING, INC. 510(k) NO: K062055(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 07-AUG-06
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
DADE BEHRING, INC. 510(k) NO: K062121(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 25-AUG-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC13
DADE BEHRING, INC. 510(k) NO: K062122(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101 SE DECISION MADE: 25-AUG-06
NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
DADE BEHRING, INC. 510(k) NO: K062128(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 21-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
DADE BEHRING, INC. 510(k) NO: K062152(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
500 GBC DR., M/S 514 SE DECISION MADE: 16-AUG-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
DADE BEHRING, INC. 510(k) NO: K062179(SPECIAL)
ATTN: SHANNON POPSON PHONE NO : 916-374-3330
2040 ENTERPRISE BLVD. SE DECISION MADE: 23-AUG-06
WEST SACRAMENTO, CA 95691 510(k) STATEMENT
DEVICE: DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONT
DADE BEHRING, INC. 510(k) NO: K062191(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
500 GBC DR., M/S 514 SE DECISION MADE: 21-AUG-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K062236(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX BOX 6101, M/S 514 SE DECISION MADE: 21-AUG-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL
DADE BEHRING, INC. 510(k) NO: K062276(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-372-1900
2040 ENTERPRISE BLVD. SE DECISION MADE: 23-AUG-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
DADE BEHRING, INC. 510(k) NO: K062293(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 916-374-3174
2040 ENTERPRISE BLVD. SE DECISION MADE: 24-AUG-06
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND
DAKOCYTOMATION CALIFORNIA, INC. 510(k) NO: K060423(TRADITIONAL)
ATTN: TIFFANY D ALMEROTH PHONE NO : 805-566-3041
6392 VIA REAL SE DECISION MADE: 15-AUG-06
CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DARCO LOCKING BONE PLATE SYSTEM
DARCO INTERNATIONAL, INC. 510(k) NO: K061808(TRADITIONAL)
ATTN: MARK S COOPER PHONE NO : 304-522-4883
810 MEMORIAL BLVD. SE DECISION MADE: 17-AUG-06
HUNTINGTON, WV 25701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOKNOTLESS AND LUPINE PLUS ANCHORS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K062170(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 781-251-2794
325 PARAMOUNT DR. SE DECISION MADE: 22-AUG-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUPUY S-ROM STD HIP STEM PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K061221(SPECIAL)
ATTN: ANNE SCHULER PHONE NO : 574-372-7098
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-AUG-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062116(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-AUG-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACE CPSXL BONE CEMENT
DFINE, INC. 510(k) NO: K061531(TRADITIONAL)
ATTN: ROBERT D POSER PHONE NO : 408-725-1515
19450 STEVENS CREEK BLVD. SE DECISION MADE: 30-AUG-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CUPERTINO, CA 95014
DEVICE: DMS 300-7
DIAGNOSTIC MONITORING SOFTWARE 510(k) NO: K062007(SPECIAL)
ATTN: WILLIAM PARSONS PHONE NO : 714-953-2653
292 KINGSBURY, 32B SE DECISION MADE: 16-AUG-06
P.O. BOX 3109 510(k) SUMMARY AVAILABLE FROM FDA
STATELINE, NV 89449
DEVICE: PREMIER 11 HOLTER
DIAGNOSTIC MONITORING SOFTWARE 510(k) NO: K062088(SPECIAL)
ATTN: WILLIAM PARSONS PHONE NO : 714-953-2653
292 KINGSBURY GRADE, #32 SE DECISION MADE: 25-AUG-06
P.O. BOX 3109 510(k) SUMMARY AVAILABLE FROM FDA
STATELINE, NV 89449
DEVICE: ENZY-WELL SYPHILIS IGG, MODEL 91106
DIESSE DIAGNOSTICA SENESE S.P.A 510(k) NO: K050590(TRADITIONAL)
ATTN: GLORIA SCHLANSER PHONE NO : 305-573-3967
555 NE 34TH ST #1905 SE DECISION MADE: 10-AUG-06
MIAMI, FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERT-X
DIREX SYSTEMS CORP. 510(k) NO: K061873(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 339-502-6013
437 TURNPIKE ST. SE DECISION MADE: 18-AUG-06
CANTON, MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER MEDILAS H 20 LASER
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K061455(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 01-AUG-06
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSALET 7700 CARE CENTER
DRAEGER MEDICAL INFANT CARE, INC. 510(k) NO: K053399(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-682-8691
330 JACKSONVILLE RD. SE DECISION MADE: 04-AUG-06
HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
EBI, L.P. 510(k) NO: K061978(SPECIAL)
ATTN: DEBRA BING PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 11-AUG-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K062134(SPECIAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 22-AUG-06
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOCHROME LCD MONITOR, RADIFORCE, GS320
EIZO NANAO CORPORATION 510(k) NO: K062053(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 07-AUG-06
MATTO-SHI 510(k) SUMMARY AVAILABLE FROM FDA
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
ELEKTA INSTRUMENT AB 510(k) NO: K061941(TRADITIONAL)
ATTN: PETER LOWENDAHL PHONE NO : 46 8 58725400
KUNGSTENSGATAN 18 SE DECISION MADE: 21-AUG-06
P.O.BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN S-103 93
DEVICE: PEDI-SPIDER STRAP
EMERGENCY PRODUCTS AND RESEARCH 510(k) NO: K061721(TRADITIONAL)
ATTN: MARK MOEHLER PHONE NO : 330-673-5003
890 WEST MAIN STREET SE DECISION MADE: 17-AUG-06
KENT, OH 44240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE CN2 SYSTEM
ENDOCARE, INC. 510(k) NO: K062175(SPECIAL)
ATTN: ALDEN KAY PHONE NO : 949-450-5424
201 TECHNOLOGY DR. SE DECISION MADE: 28-AUG-06
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
ESAOTE EUROPE B.V. 510(k) NO: K061755(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N. MERIDIAN STREET SE DECISION MADE: 07-AUG-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032
DEVICE: SPIDERX EMBOLIC PROTECTION DEVICE
EV3 INC 510(k) NO: K062201(SPECIAL)
ATTN: BRENDA JOHNSON PHONE NO : 763-398-7238
9600 54TH AVENUE NORTH SE DECISION MADE: 11-AUG-06
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
EXCEL TECH. LTD. 510(k) NO: K061269(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 905-829-5300
2568 BRISTOL CIRCLE SE DECISION MADE: 14-AUG-06
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) STATEMENT
DEVICE: FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
FAXITRON X-RAY CORP. 510(k) NO: K061361(TRADITIONAL)
ATTN: DOUGLAS C WIEGMAN PHONE NO : 847-465-9729
225 LARKIN DR.,SUITE 1 SE DECISION MADE: 15-AUG-06
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
FCI OPHTHALMICS, INC. 510(k) NO: K061404(TRADITIONAL)
ATTN: HILLARD W WELCH PHONE NO : 508-771-6777
344 ANNABELLE POINT RD. SE DECISION MADE: 07-AUG-06
CENTERVILLE, MA 02632-2402 510(k) STATEMENT
DEVICE: FLEXIFIT HC432 FULL FACE MASK
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K061236(TRADITIONAL)
ATTN: REENA DAKEN PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 29-AUG-06
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-BLOCK, MODELS 20/19, 40/19, 55/19
FOUNDATION MILLING CENTRE 510(k) NO: K062389(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 716-838-3838
2454 MCMULLEN BOOTH RD SE DECISION MADE: 21-AUG-06
SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33759 THIRD PARTY REVIEW
DEVICE: TENOLIG
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K060367(TRADITIONAL)
ATTN: CHRISTINE QUENDEZ PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 09-AUG-06
QUIMPER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOLEY CATHETERS WITH TEMPERATURE PROBE
GE HEALTHCARE 510(k) NO: K061918(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 18-AUG-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFT
GE HEALTHCARE 510(k) NO: K061994(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 11-AUG-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12 RL ALGORITHM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K060307(TRADITIONAL)
ATTN: PATRICK ZIELINSKI PHONE NO : 262-293-1720
8200 WEST TOWER AVE. SE DECISION MADE: 04-AUG-06
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12SL ECG ANALYSIS PROGRAM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K060833(SPECIAL)
ATTN: LISA M BAUMHARDT PHONE NO : 414-362-3242
8200 WEST TOWER AVE. SE DECISION MADE: 01-AUG-06
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIO
GE OEC MEDICAL SYSTEMS 510(k) NO: K061953(TRADITIONAL)
ATTN: GREG HANSEN PHONE NO : 801-536-4525
384 WRIGHT BROTHERS DR. SE DECISION MADE: 15-AUG-06
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
GEN-PROBE, INC. 510(k) NO: K060652(TRADITIONAL)
ATTN: BRIAN J SHEA PHONE NO : 858-410-8535
10210 GENETIC CENTER DR. SE DECISION MADE: 17-AUG-06
SAN DIEGO, CA 92121-4362 510(k) STATEMENT
DEVICE: IDI-VANR ASSAY
GENEOHM SCIENCES CANADA, INC. 510(k) NO: K061686(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
PO BOX 103 SE DECISION MADE: 30-AUG-06
BALDWIN, MD 21082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED SCULPT
GENERAL PROJECT S.R.L. 510(k) NO: K053041(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 02-AUG-06
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICU
GRACE MEDICAL, INC. 510(k) NO: K061853(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000
8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 18-AUG-06
MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K061483(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 14-AUG-06
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
GUILIN WOODPECKER MEDICAL INSTRUME510(k) NO: K053555(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 21-AUG-06
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO-1000 COLPOSCOPE, MULTIPLE
GYNEX CORP. 510(k) NO: K061306(TRADITIONAL)
ATTN: KAREN CARDIFF PHONE NO : 425-882-1179
2789 152ND AVE., NE SE DECISION MADE: 07-AUG-06
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
HARDY DIAGNOSTICS 510(k) NO: K062245(TRADITIONAL)
ATTN: ANDRE HSIUNG PHONE NO : 805-346-2766
1430 WEST MCCOY LN. SE DECISION MADE: 23-AUG-06
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: HHF1 ECHELON MULTI-PURPOSE COIL
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K061950(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 18-AUG-06
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
HOFFMAN LABORATORIES, LLC 510(k) NO: K061099(TRADITIONAL)
ATTN: KEITH BOSECKER PHONE NO : 818-341-4131
9305 ETON AVENUE SE DECISION MADE: 11-AUG-06
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND
HOLOGIC, INC. 510(k) NO: K062107(SPECIAL)
ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203-731-8337
36 APPLE RIDGE ROAD SE DECISION MADE: 18-AUG-06
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
HORIBA ABX 510(k) NO: K060318(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 33 4 67147320
PARC EUROMEDECINE SE DECISION MADE: 08-AUG-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP,
HORIBA ABX 510(k) NO: K060325(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 16-AUG-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: ABX PENTRA 400: LIPOPROTEINS
HORIBA ABX 510(k) NO: K060854(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 24-AUG-06
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE
HOSPIRA, INC. 510(k) NO: K061450(TRADITIONAL)
ATTN: THOMAS SAMPOGNA PHONE NO : 224-212-4662
275 NORTH FIELD DR. SE DECISION MADE: 04-AUG-06
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
HOWMEDICA OSTEONICS CORP 510(k) NO: K053348(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 04-AUG-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT LARGE DIAMETER HIP SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K061434(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 22-AUG-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON METAL BACKED PATELLA
HOWMEDICA OSTEONICS CORP 510(k) NO: K061521(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 11-AUG-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON LOW PROFILE TIBIAL TRAY
HOWMEDICA OSTEONICS CORP 510(k) NO: K062037(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 03-AUG-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA 3 SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K062066(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 15-AUG-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIV
IDEV TECHNOLOGIES, INC. 510(k) NO: K060557(TRADITIONAL)
ATTN: TIMOTHY R PLACEK PHONE NO : 281-333-1998
1120 NASA PARKWAY, SUITE 600 SE DECISION MADE: 15-AUG-06
HOUSTON, TX 77058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
IKONISYS INC 510(k) NO: K061392(TRADITIONAL)
ATTN: S. MICHAEL SHARP PHONE NO : 203-776-0791
5 SCIENCE PARK SE DECISION MADE: 01-AUG-06
NEW HAVEN, CT 06511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XAMINER
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K061595(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
151,2340 PEGASUS WAY, NE SE DECISION MADE: 17-AUG-06
CALGARY, ALBERTA, CANADA T2E 8M5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
IMRIS, INC. 510(k) NO: K061916(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 11-AUG-06
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
IND DIAGNOSTIC INC. 510(k) NO: K060810(TRADITIONAL)
ATTN: JASON PENG PHONE NO : 604 522 1619
1629 FOSTERS WAY SE DECISION MADE: 07-AUG-06
DELTA, BC, CANADA V3M 6S7 510(k) STATEMENT
DEVICE: RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
INNOMED TECHNOLOGIES INC./RESPCARE510(k) NO: K062019(TRADITIONAL)
ATTN: FRANK PELC PHONE NO : 561-208-3778
6601 LYONS ROAD SE DECISION MADE: 17-AUG-06
SUITES B1-B4 510(k) SUMMARY AVAILABLE FROM FDA
COCONUT CREEK, FL 33073
DEVICE: ORBITAL TISSUE EXPANDER (OTE)
INNOVIA, LLC 510(k) NO: K060151(TRADITIONAL)
ATTN: STEWART B DAVIS PHONE NO : 305-378-2651
12415 SW 136 AVENUE SE DECISION MADE: 08-AUG-06
UNIT 3 510(k) SUMMARY AVAILABLE FROM FDA
MIAMI, FL 33186
DEVICE: STRAUMANN DENTAL IMPLANTS
INSTITUT STRAUMANN AG 510(k) NO: K061176(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 11-AUG-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
INTRA LASE CORP. 510(k) NO: K060372(TRADITIONAL)
ATTN: CHARLINE GAUTHIER PHONE NO : 949-859-5230
9701 JERONIMO ROAD SE DECISION MADE: 16-AUG-06
IRVINE, CA 92618-1916 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION VXC CENTRAL STATION, MODEL 4300
INVIVO CORPORATION 510(k) NO: K061675(SPECIAL)
ATTN: MARIA KEELAN PHONE NO : 407-275-3220
12601 RESEARCH PKWY. SE DECISION MADE: 02-AUG-06
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
ISCIENCE SURGICAL 510(k) NO: K062259(TRADITIONAL)
ATTN: GRACE BARTOO PHONE NO : 650-303-0985
4055 CAMPBELL AVENUE SE DECISION MADE: 15-AUG-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POW
J. MORITA USA, INC. 510(k) NO: K061701(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 25-AUG-06
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
JAN MAO INDUSTRIES CO., LTD. 510(k) NO: K062218(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 16-AUG-06
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
K-JUMP HEALTH CO., LTD. 510(k) NO: K061760(SPECIAL)
ATTN: DANNY WANG PHONE NO : 886 222 991378
NO. 56, WU KUNG 5TH RD., SE DECISION MADE: 14-AUG-06
WU KU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 248
DEVICE: KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATE
KENDALL 510(k) NO: K060972(TRADITIONAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 04-AUG-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRY LASER IMAGER, DRYPRO MODEL 832
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K061999(TRADITIONAL)
ATTN: JOJI MATSUSHIMA PHONE NO : 81 426 609607
2970 ISHIKAWA-MACHI SE DECISION MADE: 15-AUG-06
HACHIOJI-SHI, TOKYO, JAPAN 192-850510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA BIPOLAR ELECTROTOME
KSEA 510(k) NO: K061541(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-5597
600 CORPORATE POINTE SE DECISION MADE: 21-AUG-06
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAC-MAC INNERBLOC O.R. GOWN
LAC MAC, LTD. 510(k) NO: K061491(ABBREVIATED)
ATTN: JEFFREY O STULL PHONE NO : 512-288-8272
P.O. BOX 92493 SE DECISION MADE: 09-AUG-06
AUSTIN, TX 78709 510(k) STATEMENT
DEVICE: EASYSPINE SYSTEM
LDR SPINE USA 510(k) NO: K061017(SPECIAL)
ATTN: EDWARD E NEWTON PHONE NO : 512-344-3316
4030 WEST BRAKER LANE SE DECISION MADE: 10-AUG-06
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: ARX SPINAL SYSTEM
LIFE SPINE 510(k) NO: K061600(TRADITIONAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 22-AUG-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60195
DEVICE: MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K062195(SPECIAL)
ATTN: CINDY MORROW PHONE NO : 408-956-4286
1000 GIBRALTAR DR. SE DECISION MADE: 16-AUG-06
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
LITTLE DOCTOR (SHANGHAI) ELECTRONI510(k) NO: K061279(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 18-AUG-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL H
MAQUET CARDIOPULMONARY AG 510(k) NO: K061628(TRADITIONAL)
ATTN: JAMES COLLIE PHONE NO : 215-491-5245
414 MARYJOE WAY SE DECISION MADE: 22-AUG-06
WARRINGTON, PA 18976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOSTRA HLM TUBING SETS WITH SAFELINE COATING
MAQUET CARDIOPULMONARY AG 510(k) NO: K061832(TRADITIONAL)
ATTN: JAMES COLLIE PHONE NO : 215-491-5245
414 MARYJOE WAY SE DECISION MADE: 11-AUG-06
WARRINGTON, PA 18976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GA
MAUNA KEA TECHNOLOGIES 510(k) NO: K061666(SPECIAL)
ATTN: FOUAD TARABAH PHONE NO : 33 148 240345
9, RUE D'ENGHIEN SE DECISION MADE: 24-AUG-06
PARIS, FRANCE 75010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCHANNEL HTS SYSTEM
MEDCHANNEL, LLC 510(k) NO: K061831(TRADITIONAL)
ATTN: FREDERICK TOBIA PHONE NO : 617-247-9266
55 WORCESTER STREET, #3 SE DECISION MADE: 07-AUG-06
BOSTON, MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP VASCU-SHEATH II
MEDCOMP 510(k) NO: K053092(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 01-AUG-06
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
MEDCOMP 510(k) NO: K061986(TRADITIONAL)
ATTN: SUSAN MOTZER PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 03-AUG-06
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEPER
MEDICAL MONITORS LTD 510(k) NO: K060297(TRADITIONAL)
ATTN: RICHARD HYMAN PHONE NO : 612 934 48100
SUITE 407 OFFICE TOWER SE DECISION MADE: 02-AUG-06
WESTFIELD EAST GARDENS, AUSTRALIA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOMARK
MEDICAL PRODUCTS MANUFACTURING, IN510(k) NO: K061560(TRADITIONAL)
ATTN: THERON E JOHNSON PHONE NO : 970-527-7879
11495-3800 ROAD SE DECISION MADE: 18-AUG-06
PAONIA, CO 81428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND
MEDIPURE CORPORATION (M) SDN. BHD.510(k) NO: K061551(SPECIAL)
ATTN: TERENCE LIM SIN KOOI PHONE NO : 605 291 0060
LOT 12 MEDAN TASEK SE DECISION MADE: 24-AUG-06
TASEK INDUSTRAIL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
IPOH, PERAK, MALAYSIA 31400
DEVICE: MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
MEDTRONIC INC. 510(k) NO: K062041(SPECIAL)
ATTN: PAULA CORDERO PHONE NO : 763-505-0238
710 MEDTRONIC PARKWAY SE DECISION MADE: 16-AUG-06
MAIL STOP LN145 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55432
DEVICE: ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
MEDTRONIC IRELAND 510(k) NO: K061480(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-505-7863
1015 GRAMSIE ROAD SE DECISION MADE: 21-AUG-06
SHOREVIEW, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K061579(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 11-AUG-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K062073(SPECIAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-AUG-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K061938(SPECIAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 09-AUG-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-CLIP DEVICE, MODEL NC65
MEDTRONIC, INC. 510(k) NO: K062057(SPECIAL)
ATTN: DAVID D COX PHONE NO : 763-391-9251
7611 NORTHLAND DR. SE DECISION MADE: 02-AUG-06
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCATHETER "COURIER PRE-SHAPED", MODELS MPS170045-00,
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K061963(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1400
821 FOX LANE SE DECISION MADE: 04-AUG-06
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL SYSTEM "PRESIDIO-18", MODEL PC4
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K062036(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1400
821 FOX LANE SE DECISION MADE: 25-AUG-06
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUDENT STA
MILESTONE SCIENTIFIC, INC. 510(k) NO: K061904(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548
5335 WISCONSIN AVE NW SE DECISION MADE: 08-AUG-06
SUITE 440 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20015
DEVICE: MODERN MEDICAL ANTIMICROBIAL WOUND AND BURN DRESSING
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K050842(TRADITIONAL)
ATTN: BOB STILLMAN PHONE NO : 804-353-7160
1705 DABNEY ROAD SE DECISION MADE: 02-AUG-06
RICHMOND, VA 23230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION
MOELLER MEDICAL GMBH & CO. KG 510(k) NO: K053451(TRADITIONAL)
ATTN: BILL KELLEY PHONE NO :
23832 VIA MONTE SE DECISION MADE: 25-AUG-06
COTO DE CAZA, CA 92679-4001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-3
MYTECH TECHNOLOGY CO., LTD. 510(k) NO: K061959(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 22-AUG-06
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELLCOR OXIMAX N-600X PULSE OXIMETER
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K060576(TRADITIONAL)
ATTN: PATRICK GARVEY PHONE NO : 925-463-4479
4280 HACIENDA DR. SE DECISION MADE: 14-AUG-06
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
NEMOTO KYORINDO CO., LTD. 510(k) NO: K062168(TRADITIONAL)
ATTN: TOSHIO KANETAKA PHONE NO : 81 48 2503256
2-27-20 HONGO BUNKYO-KU SE DECISION MADE: 18-AUG-06
TOKYO, JAPAN 123-0033 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISTAL RADIUS LOCKING PLATING SYSTEM
NEWCLIP TECHNICS 510(k) NO: K061917(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 28-AUG-06
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LISFRANC PLATE
NEWDEAL S.A. 510(k) NO: K060474(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 03-AUG-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DM-3000 DIGITAL BLOOD PRESSURE MONITOR
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K061086(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
106 EAST 5TH AVENUE SE DECISION MADE: 10-AUG-06
MOUNT DORA, FL 32757 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K062008(SPECIAL)
ATTN: ORLY MAOR PHONE NO : 972 986 50610
4 HATZORAN ST. SE DECISION MADE: 09-AUG-06
P.O. BOX 8634 510(k) SUMMARY AVAILABLE FROM FDA
NATANYA, ISRAEL 42506
DEVICE: MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT S
NOBEL BIOCARE AB 510(k) NO: K061477(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 11-AUG-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTE
NOBEL BIOCARE AB 510(k) NO: K061478(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714 282 4800 7830
22715 SAVI RANCH PARKWAY SE DECISION MADE: 21-AUG-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM
NOBEL BIOCARE AB 510(k) NO: K061529(TRADITIONAL)
ATTN: PHUONG NGUYEN SON PHONE NO : 714-282-4800
22715 SAVI RANCH PARKWAY SE DECISION MADE: 23-AUG-06
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
NORTH AMERICAN CLINICAL LASERS, LT510(k) NO: K062248(TRADITIONAL)
ATTN: GEOFFREY D SWANK PHONE NO : 303-263-3307
2755 SO. AMES WAY SE DECISION MADE: 17-AUG-06
DENVER, CO 80227 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TELAHEART DIGITAL RECORDER
NORTHEAST MONITORING, INC. 510(k) NO: K061293(ABBREVIATED)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 25-AUG-06
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER
NOVARAD CORP. 510(k) NO: K061920(TRADITIONAL)
ATTN: PAUL SHUMWAY PHONE NO : 801-642-1001
758 EAST UTAH VALLEY DR. SE DECISION MADE: 21-AUG-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
AMERICAN FORK, UT 84003
DEVICE: MICROSELECTRON V3, MODEL 106.990
NUCLETRON CORPORATION 510(k) NO: K061354(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
8671 ROBERT FULTON DR. SE DECISION MADE: 17-AUG-06
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATERAL PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K061789(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 10-AUG-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA 180 SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K061313(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 31-AUG-06
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: MONOBLOCK PRESS-FIT HIP STEM
OMNI LIFE SCIENCE, INC. 510(k) NO: K060072(TRADITIONAL)
ATTN: EDWARD J CHEAL PHONE NO : 760-734-1550
175 PARAMOUNT DRIVE SE DECISION MADE: 24-AUG-06
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
RAYNHAM, MA 02767
DEVICE: OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL H
OMRON HEALTHCARE, INC. 510(k) NO: K061822(SPECIAL)
ATTN: DONNA DJINOVICH PHONE NO : 847-247-5713
1200 LAKESIDE DRIVE SE DECISION MADE: 02-AUG-06
BANNOCKBURN, IL 60015 510(k) STATEMENT
DEVICE: EXCEL HIGH SPEED DENTAL HANDPIECE
ORTHOSOURCE, INC. 510(k) NO: K061581(ABBREVIATED)
ATTN: LLOYD TAYLOR PHONE NO : 818-982-9445
13343 SHERMAN WAY SE DECISION MADE: 16-AUG-06
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
OSMETECH, INC. 510(k) NO: K061730(SPECIAL)
ATTN: BERNIE HEITZ PHONE NO : 770-510-4444
235 HEMBREE PARK DRIVE SE DECISION MADE: 04-AUG-06
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARAGOLFER
PARABASETEC, GMBH 510(k) NO: K060936(TRADITIONAL)
ATTN: WILLIAM JACKSON PHONE NO : 651-773-0002
2247 JENNIFER LANE SE DECISION MADE: 07-AUG-06
ST. PAUL, MN 55109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC SPRINT STAR
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K062158(TRADITIONAL)
ATTN: MIKE JUDGE PHONE NO : 804-253-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 28-AUG-06
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
PHILIPS MEDICAL SYSTEMS 510(k) NO: K061707(ABBREVIATED)
ATTN: SONGHUA ZHANG PHONE NO : 978-659-7319
3000 MINUTEMAN RD. SE DECISION MADE: 11-AUG-06
M/S 0220 510(k) STATEMENT
ANDOVER, MA 01810
DEVICE: PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K061610(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 49 703 14632031
HEWLETT-PACKARD STR.2 SE DECISION MADE: 14-AUG-06
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K062137(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 24-AUG-06
BOEBLINGEN, BADEN-WTTBG, GERMANY D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD11 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K062247(SPECIAL)
ATTN: STEVE SINGLAR PHONE NO : 978-695-2101
3000 MINUTEMAN RD. SE DECISION MADE: 18-AUG-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TREP-SURE TREPONEMAL ANTIBODY EIA
PHOENIX BIOTECH CORP. 510(k) NO: K053570(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE ROAD SE DECISION MADE: 07-AUG-06
EAST STROUDSBURG, PA 18301 510(k) STATEMENT
DEVICE: COMCASET SAFETY IV CATHETER
PITANGO MEDICAL LTD 510(k) NO: K062108(TRADITIONAL)
ATTN: BEN LEVIN PHONE NO : 972 361 30480
3A JABOTINSKI ST, 28TH FLOOR SE DECISION MADE: 08-AUG-06
DIAMOND HOUSE-DORON LEVY 510(k) SUMMARY AVAILABLE FROM FDA
RAMAT GAN, ISRAEL 52520 THIRD PARTY REVIEW
DEVICE: PLAYTEX EMBRACE PETITE BREAST PUMP
PLAYTEX PRODUCTS, INC. 510(k) NO: K061013(TRADITIONAL)
ATTN: KARIN E JORDAN PHONE NO : 201-785-8069
75 COMMERCE DR. SE DECISION MADE: 15-AUG-06
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
POROUS MEDIA CORP. 510(k) NO: K062091(TRADITIONAL)
ATTN: KEITH A ROBERTS PHONE NO : 651-653-2000
1350 HAMMOND RD. SE DECISION MADE: 08-AUG-06
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
POSSIS MEDICAL, INC. 510(k) NO: K062220(SPECIAL)
ATTN: MARK D STENOIEN PHONE NO : 763-717-1092
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 11-AUG-06
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI KNEE SURGETICS NAVIGATION SYSTEM
PRAXIM S.A 510(k) NO: K062146(SPECIAL)
ATTN: MADY BATAILH PHONE NO : 003 347 6549503
LE GRAND SABLON SE DECISION MADE: 21-AUG-06
4 AVENUE DE L'OBIOU 510(k) SUMMARY AVAILABLE FROM FDA
LA TRONCHE, FRANCE 38700
DEVICE: PRESTIGE AMERITECH FACE MASK
PRESTIGE AMERITECH 510(k) NO: K061716(ABBREVIATED)
ATTN: DAN REESE PHONE NO : 817-595-1131
7425 AIRPORT FWY. SE DECISION MADE: 14-AUG-06
FT. WORTH, TX 76118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIE
PROCTER & GAMBLE CO. 510(k) NO: K061486(TRADITIONAL)
ATTN: PHILIP J PHILLIPS PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVE, STE 575 SE DECISION MADE: 01-AUG-06
WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODRIVE SYSTEMS REPLACEMENT TURBINE
PRODRIVE SYSTEMS, INC. 510(k) NO: K062219(TRADITIONAL)
ATTN: TIM NASON PHONE NO : 866 747 8574
6062 ARMSTRONG RD. SE DECISION MADE: 04-AUG-06
SPENCERVILLE, ONTARIO, CANADA K0E 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AQUATINE EC ENDODONTIC CLEANSER
PURICORE, INC. 510(k) NO: K061689(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 610-341-1899
320 KING OF PRUSSIA ROAD SE DECISION MADE: 24-AUG-06
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
RADNOR, PA 19087
DEVICE: MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
QUANTUM ORTHOPEDICS, INC. 510(k) NO: K062004(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-0121
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 15-AUG-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COUGAR WHEELCHAIR
R82 A/S 510(k) NO: K061810(TRADITIONAL)
ATTN: KIRK MACKENZIE PHONE NO : 800-336-7684
12801 EAST INDEPENDENCE BLVD. SE DECISION MADE: 07-AUG-06
STALLINGS, NC 28105 510(k) STATEMENT
DEVICE: RESPCARE HYBRID AV MASK
RESPCARE INC. 510(k) NO: K062224(SPECIAL)
ATTN: FRANK PELC PHONE NO : 561-208-3778
6601 LYONS ROAD, SUITES B1-B4 SE DECISION MADE: 17-AUG-06
COCONUT CREEK, FL 33073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTMONITOR 2PS
RESPIRONICS, INC. 510(k) NO: K061256(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 02-AUG-06
MURRYSVILLE, PA 15668 510(k) STATEMENT
DEVICE: VITALSENSE XHR
RESPIRONICS, INC. 510(k) NO: K061870(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 31-AUG-06
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAGUCHEK XS SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K060978(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE ROAD SE DECISION MADE: 11-AUG-06
INDIANAP0LIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS IGE II IMMUNOASSAY
ROCHE DIAGNOSTICS 510(k) NO: K061970(SPECIAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 31-AUG-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K053287(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 10-AUG-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K053289(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 10-AUG-06
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK AVIVA TEST STRIPS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060620(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362
9115 HAGUE RD. SE DECISION MADE: 11-AUG-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE VALPROIC ACID
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060690(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 08-AUG-06
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TDM N-ACETYLPROCAINAMIDE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060738(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 917-521-7688
9115 HAGUE RD. SE DECISION MADE: 16-AUG-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE TDM PROCAINAMIDE
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060773(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 23-AUG-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPLATE VBR SYSTEM
RSB SPINE LLC. 510(k) NO: K061401(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 18-AUG-06
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
SCANTIBODIES LABORATORY, INC. 510(k) NO: K060578(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300
9336 ABRAHAM WAY SE DECISION MADE: 30-AUG-06
SANTEE, CA 92071 510(k) STATEMENT
DEVICE: NAUTIFLUX
SEDAT 510(k) NO: K060010(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-678-0569
8895 TOWNE CENTRE DRIVE SE DECISION MADE: 04-AUG-06
105-416 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA
DEVICE: SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
SIC INVENT AG 510(k) NO: K061500(ABBREVIATED)
ATTN: FRANZ MENEAN PHONE NO : 49 746 3995411
GRIESWEG 47 SE DECISION MADE: 08-AUG-06
MUEHLHEIM, GERMANY 78570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS ACUSON X500 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K061980(SPECIAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 17-AUG-06
P.O. BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: NAVIAID BGE DEVICE, MODEL 21-001
SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K060923(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS STREET, STE 213 SE DECISION MADE: 15-AUG-06
BEIT HAPA'AMON, BOX 124 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
SMITH & NEPHEW, INC. 510(k) NO: K061779(ABBREVIATED)
ATTN: GINO ROUSS PHONE NO : 901-399-6707
1450 BROOKS RD. SE DECISION MADE: 04-AUG-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNEE FUSION NAIL
SMITH & NEPHEW, INC. 510(k) NO: K061783(TRADITIONAL)
ATTN: JOHN REABE PHONE NO : 901-399-6670
1450 BROOKS RD. SE DECISION MADE: 10-AUG-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 43221
SMITHS MEDICAL ASD, INC. 510(k) NO: K061194(ABBREVIATED)
ATTN: BRIAN FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 24-AUG-06
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLA
SMITHS MEDICAL ASD, INC. 510(k) NO: K061513(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 01-AUG-06
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMIL
SOLARC SYSTEMS, INC. 510(k) NO: K061589(TRADITIONAL)
ATTN: BRUCE ELLIOTT PHONE NO : 705 739 9031
12 PARKER COURT SE DECISION MADE: 04-AUG-06
BARRIE, ONTARIO, CANADA L4N 2A6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL USA VBR SYSTEM
SPINAL USA 510(k) NO: K061752(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244
644 LAKELAND EAST DR., STE. A SE DECISION MADE: 15-AUG-06
FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO-EASE ENDOSCOPIC OVERTUBE
SPIRUS MEDICAL, INC. 510(k) NO: K060235(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 04-AUG-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE WIRE CONTROL CATHETER, MODEL WCC
ST. JUDE MEDICAL 510(k) NO: K061843(SPECIAL)
ATTN: SHANNON SPRINGER PHONE NO : 763-383-0900
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 01-AUG-06
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311
DEVICE: FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
ST.JUDE MEDICAL 510(k) NO: K061015(SPECIAL)
ATTN: GLENN JACQUES PHONE NO : 952-351-1356
14901 DEVEAU PLACE SE DECISION MADE: 03-AUG-06
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE
STEREOTAXIS, INC. 510(k) NO: K042850(TRADITIONAL)
ATTN: GARY RAUVOLA PHONE NO : 314-615-6913
4041 FOREST PARK AVE. SE DECISION MADE: 09-AUG-06
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN NARROW NECK IMPLANTS
STRAUMANN USA 510(k) NO: K060958(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 24-AUG-06
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS ASL PEEK SPACER SYSTEM
STRYKER SPINE 510(k) NO: K061836(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 03-AUG-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS PL PEEK SPACER SYSTEM
STRYKER SPINE 510(k) NO: K062132(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 16-AUG-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLEX HYBRID ACP SYSTEM
STRYKER SPINE 510(k) NO: K062310(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 18-AUG-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
SWEDEN DIAGNOSTICS (US), INC. 510(k) NO: K061165(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 03-AUG-06
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORS TEMPORARY ANCHORAGE SYSTEM
SYBRON DENTAL SPECIALTIES 510(k) NO: K061230(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 949-255-8766
100 BAYVIEW CIRCLE SE DECISION MADE: 03-AUG-06
SUITE 6000 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92660-8915
DEVICE: SYNTHES (USA) CLAVICLE HOOK PLATES
SYNTHES (USA) 510(k) NO: K061753(TRADITIONAL)
ATTN: DEBORAH JACKSON PHONE NO : 610-719-6948
1690 RUSSELL RD. SE DECISION MADE: 04-AUG-06
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNEX II
SYNTHES SPINE CO.LP 510(k) NO: K061891(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-719-5725
1302 WRIGHTS LANE EAST SE DECISION MADE: 18-AUG-06
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
TALIA TECHNOLOGY LTD. 510(k) NO: K061674(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. N.W. SE DECISION MADE: 23-AUG-06
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
TELEFLEX MEDICAL 510(k) NO: K061736(TRADITIONAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 18-AUG-06
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K062381(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 24-AUG-06
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
THE KENDALL COMPANY 510(k) NO: K061936(SPECIAL)
ATTN: PAUL W EVANS PHONE NO : 508-261-8203
15 HAMPSHIRE ST. SE DECISION MADE: 09-AUG-06
MANSFIELD, MA 02048-1108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
THERMO ELECTRON OY 510(k) NO: K061107(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 958 932 9100
RATASTIE 2 SE DECISION MADE: 08-AUG-06
VANTAA, FINLAND 01620 510(k) STATEMENT
DEVICE: NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
THERMOTEK, INC. 510(k) NO: K061866(TRADITIONAL)
ATTN: TONY QUISENBERRY PHONE NO : 972-242-3232
1454 HALSEY WAY SE DECISION MADE: 22-AUG-06
CARROLLTON, TX 75007 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
TYCO HEALTHCARE 510(k) NO: K061492(TRADITIONAL)
ATTN: MICHELLE KELLEY PHONE NO : 508-261-6393
15 HAMPSHIRE ST. SE DECISION MADE: 03-AUG-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE
UCP BIOSCIENCES, INC. 510(k) NO: K061457(TRADITIONAL)
ATTN: NANCY CHEN PHONE NO : 408-392-0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 21-AUG-06
SAN JOSE, CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIX ULTRASOUND SCANNER
ULTRASONIX MEDICAL CORPORATION 510(k) NO: K061827(TRADITIONAL)
ATTN: LULIA NUCA PHONE NO : 604 437 9500 X 105
310-3480 GILMORE WAY SE DECISION MADE: 04-AUG-06
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANGSTON DUAL LUMEN CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K061565(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228
6464 SYCAMORE COURT NORTH SE DECISION MADE: 02-AUG-06
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEBRON SCP CERVICAL PLATE SYSTEM
VERTEBRON, INC. 510(k) NO: K062110(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340
400 LONG BEACH BLVD. SE DECISION MADE: 16-AUG-06
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL CONNECT 4.0
VITAL IMAGES, INC. 510(k) NO: K062154(ABBREVIATED)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 10-AUG-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: VITREAACCESS, VERSION 1.0
VITAL IMAGES, INC. 510(k) NO: K062328(TRADITIONAL)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 21-AUG-06
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K061373(TRADITIONAL)
ATTN: CARELLE L KARIMIMANESH PHONE NO : 408-360-7261
5799 FONTANOSO WAY SE DECISION MADE: 01-AUG-06
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO S51 FAMILY OF IMAGING SYSTEMS
VOLCANO CORPORATION 510(k) NO: K061215(SPECIAL)
ATTN: MICHELLE J BADAL PHONE NO : 916-231-4497
2870 KILGORE RD. SE DECISION MADE: 10-AUG-06
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE PRECLUDE VESSEL GUARD
W.L. GORE & ASSOCIATES,INC 510(k) NO: K061727(TRADITIONAL)
ATTN: MICHAEL IVEY PHONE NO : 928-864-3790
1505 NORTH FOURTH ST. SE DECISION MADE: 07-AUG-06
FLAGSTAFF, AZ 86003-3000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE TOTAL KNEE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K061223(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 18-AUG-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BONE GRAFT SYRINGE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K062173(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 23-AUG-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY SYRINGE
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K053519(TRADITIONAL)
ATTN: GARY POND PHONE NO : 262-636-9755
2200 NORTHWESTERN AVE. SE DECISION MADE: 11-AUG-06
RACINE, WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCAT; XCAT FOR NEURO
XORAN TECHNOLOGIES, INC. 510(k) NO: K061834(TRADITIONAL)
ATTN: JIM BERTOLINA PHONE NO : 310-525-0701
309 N. FIRST STREET SE DECISION MADE: 07-AUG-06
ANN ARBOR, MI 48103-3301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINICA ANTERIOR LUMBAR PLATE SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K061353(TRADITIONAL)
ATTN: TIM CRABTREE PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 30-AUG-06
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
ZIMMER, INC. 510(k) NO: K061226(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354
P.O. BOX 708 SE DECISION MADE: 02-AUG-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD P
ZIMMER, INC. 510(k) NO: K061882(SPECIAL)
ATTN: MASON W ROBBINS PHONE NO : 574-371-8065
P.O. BOX 708 SE DECISION MADE: 01-AUG-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL R SERIES DEFIBRILLATOR
ZOLL MEDICAL CORPORATION 510(k) NO: K060559(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 17-AUG-06
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 269
TOTAL WITH SUMMARIES 247
TOTAL WITH STATEMENTS 22
Updated September 14, 2006
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH