FDA 510(k) Applications Received During June, 1980

FDA 510(k) Number Submission Date Device Name Applicant Contact
K801441 06/20/1980 ABBOTT/SHAW LIFE CARE PUMP MODEL 3 ABBOTT LABORATORIES
K801515 06/30/1980 ABBY II PATIENT MONITOR OR VITAL SIGNS M ABBOTT MEDICAL ELECTRONICS CO.
K801430 06/17/1980 CONTROL SYRINGE ABCO DEALERS, INC.
K801406 06/16/1980 MARK III ULTRASONIC SCANNING SYSTEM ADVANCED TECHNOLOGY LABORATORIES, INC.
K801435 06/19/1980 ORGANON ARTERIAL BLOOD SAMPLER AKZONA, INC.
K801463 06/24/1980 OJ-1 ENDODONIC ROOT CANAL FILE HOLDER ALMORE INTL., INC.
K801364 06/10/1980 AO STYLET LARYNGOSCOPE MODEL SLS AMERICAN OPTICAL CORP.
K801428 06/17/1980 CHEMDI AMERICAN STERILIZER CO.
K801413 06/16/1980 AMERLEX DIGOXIN RIA KIT AMERSHAM CORP.
K801437 06/19/1980 DISPENSING SEROLOGICAL PIPET AMT CORP.
K801333 06/03/1980 AMPCO DRESSING CHANGE TRAYS ASSOCIATED MEDICAL PRODUCTS CO.
K801331 06/03/1980 AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS ASSOCIATED MEDICAL PRODUCTS CO.
K801332 06/03/1980 AMPCO SKIN SCRUB TRAYS ASSOCIATED MEDICAL PRODUCTS CO.
K801301 06/03/1980 GOLDEN THERMAL RHINOPLASTY CAST BANDAGE AURIC, INC.
K801343 06/05/1980 B-D FILTER NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K801373 06/10/1980 BECKMAN MODEL 42 SPECTROPHOTOMETER BECKMAN INSTRUMENTS, INC.
K801389 06/13/1980 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON BIB, INC.
K801366 06/10/1980 DISPOSABLE TEMPERATURE PROBE COVER BIB, INC.
K801345 06/06/1980 KAMPNER HINGED TOE PROSTHESIS BIOMEDICS
K801498 06/27/1980 ENTRI NASOGASTRIC FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC.
K801481 06/24/1980 BMC RIAFLO SYSTEM BOEHRINGER MANNHEIM CORP.
K801311 06/03/1980 BURRON MULTI-AD SYRINGE CAP BURRON MEDICAL PRODUCTS, INC.
K801485 06/24/1980 SERIES 602 CKG RECORDER (MODIFIED) CARDIOKINETICS, INC.
K801306 06/03/1980 CLINETICS PCA COLUMN CLINETICS CORP.
K801336 06/04/1980 MODEL 900K PHOTOCOAGULATOR COHERENT MEDICAL DIVISION
K801367 06/10/1980 MODEL 336B HEARING AID COMMUNICATIONS, INC.
K801411 06/16/1980 MAY ILLUMINATED/INFUSION PIC COOPER MEDICAL DEVICES CORP.
K801312 06/03/1980 THE PROTECTORS COOPER MEDICAL DEVICES CORP.
K801354 06/09/1980 BIONICS ARTERIAL/VENOUS FISTULA NEEDLE CORDIS CORP.
K801356 06/09/1980 BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET CORDIS CORP.
K801355 06/09/1980 BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR CORDIS CORP.
K801357 06/09/1980 MODIFIED BLOOD CELL COUNTING & LYSING COULTER ELECTRONICS, INC.
K801380 06/11/1980 CROWN DELTA SILICONE IMPRESSION MATERIAL CROWN DELTA CORP.
K801377 06/11/1980 CYBER 120 HEMODIALYZER CYBEREX CORP.
K801291 06/02/1980 EC-4 PLETHYSMOGRAPH D. E. HOKANSON, INC.
K801352 06/09/1980 HEMORRHOIDAL LIGATION INSTR. SYSTEM DEPUY, INC.
K801421 06/17/1980 TUBE HOLDER DEVON INDUSTRIES, INC.
K801473 06/24/1980 CINOXACIN 100 MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K801474 06/24/1980 TRIMETHOPRIM 5MCG. SENSITIVITY DISCS DIFCO LABORATORIES, INC.
K801300 06/02/1980 DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) E.I. DUPONT DE NEMOURS & CO., INC.
K801469 06/24/1980 BONN MICRO IRIS HOOK (NON-STERILE) #7613 EDWARD WECK, INC.
K801467 06/24/1980 DODICK LENS HOLDING FORCEPS EDWARD WECK, INC.
K801468 06/24/1980 FRAZIER-FERGUSON SUCTION TUBES EDWARD WECK, INC.
K801465 06/24/1980 GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE EDWARD WECK, INC.
K801466 06/24/1980 LEIGH MEASURING SCALE #7725 EDWARD WECK, INC.
K801470 06/24/1980 MICRO CLIP STERILIZING CASE #65199 EDWARD WECK, INC.
K801444 06/20/1980 SKIN STAPLE REMOVER #523770 EDWARD WECK, INC.
K801445 06/20/1980 SKIN STAPLER HANDLE 523700/CARTRIDGES EDWARD WECK, INC.
K801439 06/20/1980 MODEL 5100 ELECTROCHEMICAL DETECTOR ENVIRONMENTAL SCIENCES ASSOC., INC.
K801374 06/10/1980 PROXIMATE (TMD) TISSUE MEASURING DEVICE ETHICON, INC.
K801344 06/05/1980 EXTRACORPOREALS' ALTERNATE MEMBRANE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K801429 06/17/1980 SUNSATION FASHION, INC.
K801381 06/11/1980 FITE FIXATION TOY FOR OCULAR EXAM FITE ENGINEERING CORP.
K801379 06/11/1980 CUFFED TRACHEA TUBE FOR USE W/PERTRACH FREDERIC J. TOYE, M.D.
K801414 06/16/1980 ERYTHROCATH INTRAVENOUS CATHETER PLA. U. G.D. SEARLE AND CO.
K801415 06/16/1980 LATEX FOLEY CATHETER (HYDROMER COATED) G.D. SEARLE AND CO.
K801480 06/24/1980 GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ GAMBRO, INC.
K801479 06/24/1980 GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- GAMBRO, INC.
K801370 06/10/1980 GF-120-L DIALYZER GAMBRO, INC.
K801378 06/11/1980 HIPP BUFFER(NON-BARBITAL), P/N GELMAN SCIENCES, INC.
K801454 06/24/1980 DATASON RTL GENERAL ELECTRIC CO.
K801320 06/03/1980 SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 GENERAL ELECTRIC CO.
K801322 06/05/1980 MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS GRAPHIC CONTROLS CORP.
K801321 06/05/1980 PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE GRAPHIC CONTROLS CORP.
K801449 06/23/1980 BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 HEALTH DIAGNOSTICS CORP.
K801318 06/08/1980 HELENA ULTRA SENSITIVE CPK REAGENT/DILUE HELENA LABORATORIES
K801504 06/27/1980 HOLLISTER DRAINAGE POUCH HOLLISTER, INC.
K801503 06/27/1980 HOLLISTER KARAYA SEAL RING HOLLISTER, INC.
K801313 06/03/1980 COMPRESSION MOLDING OF UHMWPE HOWMEDICA CORP.
K801471 06/24/1980 SUPER BANISH DEODORANT HOWMEDICA CORP.
K801359 06/09/1980 PRUITT VASCULAR SHUNT IDEAS FOR MEDICINE, INC.
K801513 06/30/1980 TISSUE PROCESSING SYSTEM INNOVATIVE MEDICAL SYSTEMS, INC.
K801350 06/09/1980 ACUVAC(TM) SUCTION RESERVOIR 400CC AND INNOVATIVE SURGICAL PRODUCTS INC.
K801382 06/12/1980 DISPOSABLE SURGICAL HEAD SUPPORT INNOVATIVE SURGICAL PRODUCTS INC.
K801456 06/24/1980 F/LS MCA APPLICATION SOFTWARE INSTRUMENTATION LABORATORY CO.
K801337 06/04/1980 CYBERLITH IX IMPLANTABLE PULSE GENERATOR INTERMEDICS, INC.
K801338 06/04/1980 CYBERLITH PROGRAMMER INTERMEDICS, INC.
K801450 06/20/1980 INTERMEDICS THIN LITH IV SERIES UNIPOLAR INTERMEDICS, INC.
K801339 06/04/1980 TELEMETRY DECODER INTERMEDICS, INC.
K801308 06/03/1980 FIAX TEST KIT FOR TOBRAMYCIN QUANTITA INTL. DIAGNOSTIC TECHNOLOGY
K801410 06/16/1980 HEMOHLOBIN A2 CONTROL-LYOPHILIZED ISOLAB, INC.
K801362 06/09/1980 ALBUMIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801363 06/09/1980 COMPLEMENT C3 NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801361 06/09/1980 COMPLEMENT C4 NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801433 06/18/1980 HAPTOGLOBIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801432 06/18/1980 HEMOPEXIN NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801434 06/18/1980 J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS J.T. BAKER CHEMICAL CO.
K801304 06/08/1980 CAMLOC SYRINGE BIOPSY KIT JOHANNAH MEDICAL SERVICES, INC.
K801388 06/13/1980 OH-HARRIS JOHNSON & JOHNSON PROFESSIONALS, INC.
K801418 06/17/1980 KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT KEELER OPTICAL PRODUCTS LTD.
K801358 06/09/1980 NEW FREEDOM ANYDAY PANTILINERS KIMBERLY-CLARK CORP.
K801349 06/09/1980 LOSEFF BALLOON TYPE SELF-RETENTION WOUND LOSEFF MEDICAL DESIGNERS, LTD.
K801490 06/26/1980 DIGOXIN EIA KIT M.A. BIOPRODUCTS
K801462 06/24/1980 SPOR-O-THERM MDT CORP., INC.
K801495 06/26/1980 CARDIO-PULMONARY EXERCISE STRESS SYSTEM MEDICAL GRAPHICS CORP.
K801497 06/26/1980 INFANT VENTILATORY MEASUREMENT SYSTEM MEDICAL GRAPHICS CORP.
K801496 06/26/1980 PULMONARY LAB AUTOMATION SYSTEM MEDICAL GRAPHICS CORP.
K801323 06/06/1980 HI-TEMP SURGICAL CAUTERY MEDICAL PRODUCTS DEVELOPMENT, INC.
K801451 06/23/1980 ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM MEDICAL, INC.
K801457 06/24/1980 ACCU-CORE DISPOSABLE BIOPSY NEEDLE MEDLINE INDUSTRIES, INC.
K801368 06/10/1980 A2 IMAGE PROCESSING SYSTEM MEDTRONIC VASCULAR
K801384 06/11/1980 MYELOSTAT DORSAL CORD STIMULATOR, ETC. MEDTRONIC VASCULAR
K801491 06/26/1980 MRI HCG-BETA RIA KIT CAT. #MR-10100 MICROANALYTIC RESEARCH, INC.
K801426 06/17/1980 TISSUE-TEK III MICROJECT DISP. BLADE SYS MILES LABORATORIES, INC.
K801427 06/17/1980 TISSUE-TEK III MINI-RAPID PROCESSOR MILES LABORATORIES, INC.
K801500 06/27/1980 ULTRAFREE CALCIUM FILTER MILLIPORE CORP.
K801512 06/30/1980 DOPPLER ULTRASONIC STETHOSCOPE MOUNTAIN MEDICAL EQUIPMENT, INC.
K801459 06/24/1980 ELECTRO-ACUSCOPE-70 NEBRENSKY CORP.
K801506 06/30/1980 CERTIFIED BLOOD BANK SALINE NOBEL SCIENTIFIC INDUSTRIES, INC.
K801346 06/09/1980 NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA NOBEL SCIENTIFIC INDUSTRIES, INC.
K801425 06/17/1980 RH CONTROL NORTH AMERICAN BIOLOGICALS, INC.
K801461 06/24/1980 THERMA-SHIELD OLYMPIC MEDICAL CORP.
K801452 06/23/1980 OROTRACHEAL INTUBATION ENDOSCOPE OLYMPUS CORP.
K801385 06/13/1980 K1 POTASSIUM ACETATE ADDITIVE ORGANON TEKNIKA CORP.
K801440 06/20/1980 SORB 10 DIALYSATE INFUSATE C1 INFUSATE ORGANON TEKNIKA CORP.
K801507 06/30/1980 ANTIGEN CONTROL CELLS ORTHO DIAGNOSTICS, INC.
K801436 06/19/1980 ORTHOPEDIC LOWER EXTREMITY SUSPENSION ORTHOPEDIC SYSTEMS, INC.
K801448 06/23/1980 OTICON MODEL E17P EARETTE HEARING AID OTICON CORP.
K801455 06/24/1980 LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM PACESETTER SYSTEMS
K801416 06/16/1980 PACEPATH MODEL 810 PACESETTER SYSTEMS
K801417 06/16/1980 PACEPATH MODEL 819 PACESETTER SYSTEMS
K801460 06/24/1980 PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT PACIFIC HEMOSTASIS
K801446 06/20/1980 PFIZER PZ-CT SCANNER PFIZER MEDICAL SYSTEMS, INC.
K801408 06/16/1980 CINESCOPE III PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K801407 06/16/1980 SYNERVIEW MODEL 6545 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K801386 06/13/1980 PRE-DENT SYSTEM OR PRE-DENT II PRE-DENT SYSTEM
K801443 06/20/1980 P-S SUCTION RESERVOIR PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K801442 06/20/1980 P-S SURGICAL DRAIN PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K801317 06/03/1980 QUADRA WHEELCHAIR, QUADRA CHAIR, ETC. QUADRA WHEELCHAIRS, INC.
K801351 06/09/1980 EPILATOR, MODEL CP-16 R. A. FISCHER CO. CORP.
K801493 06/26/1980 ALA SWAB REMEL CO.
K801305 06/03/1980 HIPPURATE DISK REMEL CO.
K801492 06/26/1980 PORPHYRIN (ALA) DISK REMEL CO.
K801423 06/17/1980 RTM SYSTEM (REMOTE TEMPERATURE MONITOR) REMOTE TECHNOLOGIES, INC.
K801453 06/24/1980 FINGER, HAND & WRIST EXERCISER ROBERT W. SLACK
K801299 06/02/1980 COBAS CK-NAC REAGENT ROCHE ANALYTICAL INSTRUMENTS, INC.
K801295 06/02/1980 COBAS REAGENT FOR A-AMYLASE ROCHE ANALYTICAL INSTRUMENTS, INC.
K801296 06/02/1980 COBAS REAGENT FOR CHOLESTEROL ROCHE ANALYTICAL INSTRUMENTS, INC.
K801297 06/02/1980 COBAS REAGENT FOR GLUCOSE RAPID ROCHE ANALYTICAL INSTRUMENTS, INC.
K801298 06/02/1980 COBAS REAGENT FOR TRIGLYCERIDES & COBAS ROCHE ANALYTICAL INSTRUMENTS, INC.
K801365 06/10/1980 KOLD WRAP ROMAINE, INC.
K801422 06/17/1980 SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. SANDARE CHEMICAL CO., INC.
K801372 06/10/1980 ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR SHERWOOD MEDICAL CO.
K801371 06/10/1980 ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. SHERWOOD MEDICAL CO.
K801375 06/11/1980 SHILEY CARDIOTOMY RESERVOIR W/FILTER SHILEY, INC.
K801508 06/30/1980 SIEMENS-ELEMA PULSE GENERATOR 625 SIEMENS ELEMA AB
K801324 06/03/1980 SIEMENS-ELEMA PULSE GENERATOR 668 SIEMENS ELEMA AB
K801489 06/26/1980 EZ ON SAFETY PONCHO SKIL-CARE CORP.
K801478 06/24/1980 SSC8 SORENSON SUBCLAVIAN CATHETER SORENSEN RESEARCH
K801597 06/24/1980 PFT CALIBRATOR SPITAL MEDICAL, INC.
K801424 06/17/1980 ESTRIOL RIA KIT FOR USE WITH GAMMAFLO SQUIBB & SONS, INC.
K801458 06/24/1980 WINTER HEAD DRESSING STERIDYNE CORP.
K801309 06/03/1980 RITTER STERILIZER SYBRON CORP.
K801499 06/27/1980 AGA UV PHOTOMETER SYVA CO.
K801475 06/24/1980 APPLICATION OF EMIT AED ASSAYS SYVA CO.
K801476 06/24/1980 APPLICATION OF EMIT THEOPHYLLINE ASSAY SYVA CO.
K801341 06/05/1980 TAN YEAR ROUND SUN BED TAN-YEAR ROUND, INC.
K801509 06/30/1980 HI-M-TEST FOR METHADONE TEST #2 TECHNAM, INC.
K801314 06/03/1980 VOCON MODEL VC526 TEKNAR, INC.
K801293 06/02/1980 ACOUSTIC IMPEDANCE METER, MODEL TA-4D TELEDYNE AVIONICS DIV. OF TELEDYNE
K801325 06/03/1980 CLINICAL AUDIOMETER MODEL TA-200 TELEDYNE AVIONICS DIV. OF TELEDYNE
K801393 06/13/1980 AIR ASPIRATOR NEEDLE TEXAS MEDICAL PRODUCTS, INC.
K801398 06/13/1980 AORTIC AND FEMORAL PERFUSION CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801394 06/13/1980 CARDIOPULMONARY BYPASS PUMP TUBING TEXAS MEDICAL PRODUCTS, INC.
K801401 06/13/1980 CARDIOPULMONARY BYPASS TUBING TEXAS MEDICAL PRODUCTS, INC.
K801399 06/13/1980 CORONARY PERFUSION CONNECTOR PLUG TEXAS MEDICAL PRODUCTS, INC.
K801404 06/13/1980 DISPOSABLE PARALLEL "Y" CONNECTORS TEXAS MEDICAL PRODUCTS, INC.
K801405 06/13/1980 DISPOSABLE PERFUSION CONNECTORS TEXAS MEDICAL PRODUCTS, INC.
K801403 06/13/1980 DISPOSABLE PERFUSION SET TEXAS MEDICAL PRODUCTS, INC.
K801400 06/13/1980 DISPOSABLE SUCKER SYSTEM TEXAS MEDICAL PRODUCTS, INC.
K801392 06/13/1980 DISPOSABLE SUMP SETS TEXAS MEDICAL PRODUCTS, INC.
K801402 06/13/1980 QUICKIE PRIME CARDIOP. BYPASS PERF. INTR TEXAS MEDICAL PRODUCTS, INC.
K801396 06/13/1980 SAPHENOUS VEIN CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801395 06/13/1980 VASCULAR CLAMP TEXAS MEDICAL PRODUCTS, INC.
K801397 06/13/1980 VENA CAVA CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801329 06/03/1980 ANSPACH INSTRUMENT CADDY THE ANSPACH EFFORT, INC.
K801330 06/03/1980 ANSPACH LEG SUPPORT THE ANSPACH EFFORT, INC.
K801326 06/03/1980 ANSPACH OPERATING TABLE SUPPORT/SPINAL THE ANSPACH EFFORT, INC.
K801328 06/03/1980 THE EQUALIZER THE ANSPACH EFFORT, INC.
K801327 06/03/1980 THE EXTRACTOR I TM THE ANSPACH EFFORT, INC.
K801501 06/27/1980 UV URIC ACID STANDARDS THE DOW CHEMICAL CO.
K801514 06/30/1980 TIMETER PRODUCED PURRITAN BENNETT O2 ADP TIMETER INSTRUMENT CORP.
K801360 06/09/1980 CARDIOTOMY RESERVOIR WITH FILTER TRAVENOL LABORATORIES, S.A.
K801391 06/13/1980 DISC 120 TRANSPORTER TRAVENOL LABORATORIES, S.A.
K801409 06/16/1980 GAMMADAB B-HCG RADIOIMMUNOASSAY KIT TRAVENOL LABORATORIES, S.A.
K801438 06/19/1980 CENTRIFICHEM SYSTEM MANAGER UNION CARBIDE CORP.
K801310 06/03/1980 THE MAGTEC SYSTEM VALLEY FORGE SCIENTIFIC CORP.
K801383 06/11/1980 ECA CREAM REFORMULATION VANARAY LABORATORIES, INC.
K801353 06/09/1980 PARKE-DAVIS SURGICAL LIGHT WARNER-LAMBERT CO.
K801335 06/04/1980 UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE WARNER-LAMBERT CO.
K801431 06/18/1980 PAN-AM MYELOGRAM TRAY WATERS ASSOC., INC.
K801303 06/03/1980 MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST WESTERN LABORATORIES CORP.
K801292 06/02/1980 SURGICAL INSTRUMENTS WILLIAM SKIDMORE & CO., LTD.
K801342 06/05/1980 DISPOSABLE ARTICULATOR WILLIAMS GOLD REFINING CO., INC.


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