FDA 510(k) Decisions During October, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781556 10/17/1978 PRESSURE INFUSION CUFF ABBOTT LABORATORIES
K781354 10/17/1978 PILLOWS- SINGLE PATIENT USE ABCO DEALERS, INC.
K781227 10/17/1978 TOWELS, SHEETS, PILLOWCASES ABCO DEALERS, INC.
K781699 10/24/1978 EAGLE PAC/VISIBLE SEAL AMERICAN STERILIZER CO.
K781684 10/24/1978 STERILIZER, EAGLE 2000 AMERICAN STERILIZER CO.
K781581 10/17/1978 SURGICAL LIGHT 22" SERIES AMERICAN STERILIZER CO.
K781685 10/27/1978 RIA KIT, LH AMERSHAM CORP.
K781604 10/10/1978 CDC ANAEROBE BLOOD AGAR ANAEROBE SYSTEMS
K781603 10/10/1978 CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH. ANAEROBE SYSTEMS
K781602 10/10/1978 CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM. ANAEROBE SYSTEMS
K781441 10/10/1978 BCG ALBUMIN REAGET ANALYTICAL & RESEARCH CHEMICALS, INC.
K781460 10/10/1978 CHLORIDE REAGENT ANALYTICAL & RESEARCH CHEMICALS, INC.
K780776 10/03/1978 ARCOBIOLITH PACEMAKER MODEL ARCO MEDICAL PRODUCTS CO.
K781333 10/24/1978 CENTRAL CATHETER TRAY ARGON MEDICAL CORP.
K781658 10/17/1978 PROJECTOR, ACCU-CHART ACUITY BAUSCH & LOMB, INC.
K781364 10/17/1978 PINT BOTTLE WELL BAXA CORP., SUB. OF COOK GROUP, INC.
K781303 10/02/1978 BIO-PRO UNIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781436 10/03/1978 DELTA TEST ASSAY, HDL CHLORESTEROL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781501 10/03/1978 ENZAC INCUBATOR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781153 10/17/1978 KIDNEY, ARTIFICIAL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781669 10/23/1978 RESPIRATORY EXERCISOR, VOLUME PULSE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781442 10/03/1978 BECKMAN ASTRA SYSTEM BECKMAN INSTRUMENTS, INC.
K781432 10/03/1978 STAT ULTRA VIOLET LIQUID BECKMAN INSTRUMENTS, INC.
K781300 10/16/1978 OXYGEN CONCENTRATOR BENDIX INSTRUMENTS & LIFE SUPPORT DIV
K780721 10/17/1978 IDENTI-CLAMPS BERKELEY BIO-MEDICAL, INC.
K780720 10/17/1978 IDENTI-LOOPS BERKELEY BIO-MEDICAL, INC.
K781683 10/13/1978 NURITE II, SINGLE BIO-MEDICAL SYSTEMS CORP.
K781643 10/03/1978 ACID FAST KIT BIOSCIENTIFIC
K781584 10/10/1978 GRAM STAIN KIT BIOSCIENTIFIC
K781587 10/10/1978 HEMATOLOGY STAIN PACK BIOSCIENTIFIC
K781585 10/10/1978 HEMATOXYLIN STAIN "HARRIS" BIOSCIENTIFIC
K781582 10/10/1978 PAPANICOLAOU STAIN "EA-36" BIOSCIENTIFIC
K781583 10/10/1978 PAPANICOLAOU STAIN :EA-50: BIOSCIENTIFIC
K781588 10/10/1978 PAPANICOLAOU STIAN "OG-6" BIOSCIENTIFIC
K781734 10/24/1978 SODIUM CHLORIDE, 0.85% BIOSCIENTIFIC
K781644 10/03/1978 ANTIBIOTIC NEPHELOMETER BIOVATION, INC.
K781538 10/03/1978 SINGLE VIAL LDH-L TRIS BOEHRINGER MANNHEIM CORP.
K781515 10/02/1978 MODEL LS-80 ADULT VENTILATION MONITOR BOURNS MEDICAL SYSTEMS, INC.
K781485 10/16/1978 PATIENT CIRCUIT MANIFOLD BOURNS MEDICAL SYSTEMS, INC.
K781681 10/17/1978 PHIPIOLOGICAL SYNCHRONIZER PART#205 BRATTLE INSTRUMENT CORP.
K781661 10/17/1978 THERMOMETER, DIGITAL ELEC. MODEL 4755 BRITISH AEROSPACE, INC.
K781607 10/17/1978 STREP-TEX BURROUGHS WELLCOME CO.
K781527 10/03/1978 RIA SYSTEM FOR HUMAN FE-RITIN CALBIOCHEM-BEHRING CORP.
K781353 10/10/1978 PAPILLOTOME CUTTING SNARE CAMERON-MILLER, INC.
K781514 10/17/1978 ECG ELECTRODE, 2021, 2022, 2032, 2033 CARDIO-DYNAMICS LABORATORIES, INC.
K781484 10/27/1978 CASTLE MODEL 3146 GAS AERATOR CASTLE CO.
K781542 10/10/1978 HEATED NEBULIZER CHEMETRON MEDICAL PRODUCTS, INC.
K781537 10/10/1978 NEBULIZER/HUMIDIFIER CHEMETRON MEDICAL PRODUCTS, INC.
K781650 10/17/1978 TERRY KERATOMETER CLIFFORD M. TERRY, M.C.
K781369 10/03/1978 MICRODILUTION ANAEROBE ID. PANEL CNR LABS
K781368 10/03/1978 MICRODILUTION GRAM-NEGATIVE ID. PANEL CNR LABS
K781367 10/03/1978 MICRODILUTION STREP ID. PANEL CNR LABS
K781579 10/05/1978 MODIFIED STERILE DISPOSABLE STOPCOCKS COBE LABORATORIES, INC.
K781558 10/10/1978 PRESSURE MONITORING INJECTION LINES COBE LABORATORIES, INC.
K781452 10/24/1978 BAYLOW VISUAL ACUITY TESTER CODMAN & SHURTLEFF, INC.
K781412 10/11/1978 OSCILLATING KNIFE AND ACCESSORIES CODMAN & SHURTLEFF, INC.
K780719 10/10/1978 FUNGUS FIGHTER INSOLES COMBE, INC.
K781534 10/24/1978 SURG-O-PAK PREP PAD CONVERTORS
K781393 10/30/1978 VARIABLE STIFFNESS WIRE GUIDE COOK, INC.
K781628 10/27/1978 HEMO-W SYSTEM COULTER ELECTRONICS, INC.
K781576 10/03/1978 MINI-KEM COULTER ELECTRONICS, INC.
K781166 10/15/1978 MONITOR, HEART RATE CYBERNETIC MEDICAL, INC.
K781381 10/10/1978 EMIT METHATREXATE ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K781593 10/17/1978 RIA CONTROLS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781600 10/31/1978 MISTY-OX PREFILLED HUMIDIFIER, DISP. DAVCO
K781210 10/10/1978 HEAT EXCHANGER, FHX-14 DELTA MEDICAL INDUSTRIES
K781710 10/24/1978 BUFFER, COLLAGEN REAGENT AND DILUENT DIAGNOSTICA, INC.
K781642 10/10/1978 RA-I DIASONICS, INC.
K781645 10/27/1978 AUTODILUTER 2 DYNATECH LABORATORIES, INC.
K781646 10/27/1978 SRD-2 DYNATECH LABORATORIES, INC.
K781659 10/24/1978 ASSAY SYSTEM, GAMMAFLO, AUTOMATED E. R. SQUIBB & SONS, INC.
K781660 10/24/1978 RIA, DIGOXIN E. R. SQUIBB & SONS, INC.
K781631 10/10/1978 ECHO-OIL ECHO LABORATORIES, INC.
K781716 10/24/1978 BLADE, 20 ANGLE/MICRO BLADE HOLDER EDWARD WECK, INC.
K781547 10/24/1978 MICROSURGURY VISIBILITY BACKGROUND ETHICON, INC.
K781634 10/03/1978 VISUALAX FARRALL INSTRUMENTS, INC.
K781609 10/24/1978 ALKALINE PHOSPHATASE IN SERUM FISHER SCIENTIFIC CO., LLC.
K781466 10/03/1978 AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT FISHER SCIENTIFIC CO., LLC.
K781610 10/24/1978 BILIRUBIN DETERMINTAITON IN SERUM FISHER SCIENTIFIC CO., LLC.
K781611 10/24/1978 CHOLESTEROL DET. IN SERUM FISHER SCIENTIFIC CO., LLC.
K781690 10/27/1978 L-CYSTEINE HYDROCHLORIDE FISHER SCIENTIFIC CO., LLC.
K781102 10/17/1978 DIALYZER, DISP., COIL, LUNDIA GAMBRO, INC.
K781673 10/17/1978 MAXI-CAMERA 535 GENERAL ELECTRIC CO.
K781524 10/17/1978 MAXIRAY 125 TUBE UNIT GENERAL ELECTRIC CO.
K781318 10/03/1978 DYNATRON 406 ELECTROTHERAPY APPARATUS GENERAL THERAPHYSICAL, INC.
K781315 10/03/1978 MUSCLE STIMULATION APPARATUS GENERAL THERAPHYSICAL, INC.
K781319 10/03/1978 THERAPY APPAR. 422 INTERFERENTIAL GENERAL THERAPHYSICAL, INC.
K781314 10/03/1978 THERAPY UNIT & ELECTRODIAG. GENERAL THERAPHYSICAL, INC.
K781317 10/03/1978 ULTRASONIC THERAPY APPARATUS, 407 GENERAL THERAPHYSICAL, INC.
K781590 10/03/1978 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K781676 10/17/1978 X-RAY STAND, PORTABLE GENERAL X-RAY, INC.
K781494 10/31/1978 EEG LEAD ASSEMBLY GRAPHIC CONTROLS CORP.
K781147 10/10/1978 EPILATOR, EASE-MULTI-MODE GREENLEAF-CARTER ENTERPRISES, INC.
K781548 10/17/1978 UMBILICAL CORD CLAMP HOLLISTER, INC.
K781048 10/03/1978 THC DIRECT RIA KIT IMMUNALYSIS CORPORATION
K781394 10/16/1978 DISPOSABLE INCENTIVE SPIROMETER INHAL-O-TECH MEDICAL PLASTIC
K781568 10/18/1978 PACEMAKER, MODEL 251-01 INTERMEDICS, INC.
K781420 10/03/1978 SPECIALTY SPONGES IPCO CORP.
K781580 10/11/1978 PERFIT DENTAL RESTORATIVE COMPOSITE LOCITE CORP.
K781578 10/10/1978 RIA QUANT B-HCG TEST KIT MALLINCKRODT CRITICAL CARE
K781477 10/03/1978 TRIGLYCERIDES TEST KIT MALLINCKRODT CRITICAL CARE
K781544 10/03/1978 EPPENDORF "PCP 6121" MARILYN L. AMICK
K781761 10/27/1978 KENDRICK EXTRICATION DEVICE MEDI-KED, INC.
K781336 10/10/1978 SURGITEK DISPOSABLE FLO-RESTER MEDICAL ENGINEERING CORP.
K781606 10/03/1978 MEPA-1 BLOOD ANALYZER MEDICO ELECTRONIC, INC.
K781352 10/27/1978 STRAIN GAUGE PLETHYSMOGRAPH MEDIMATIC
K781252 10/03/1978 GENERATOR, PULSE, MODEL 5997 MEDTRONIC VASCULAR
K781208 10/03/1978 GENERATORS, PULSE, MODELS 5988/5989 MEDTRONIC VASCULAR
K781348 10/03/1978 FOCISCAN ECHOVISOR SYSTEM METRIX TEKNIKA, INC.
K781350 10/17/1978 OBJECTS PRECISION HANDLING TEST KIT METRO. HOSPITAL & HEALTH CENTER
K781392 10/24/1978 CYTOMEGILISH TEST KIT MICROBIOLOGICAL ASSOC.
K781591 10/16/1978 NEBULIZER/HUMIDIFIER MODEL EH 147B MISTOGEN EQUIPMENT CO.
K781559 10/03/1978 LIFTING CHAIR & LIFTING LAVATORY SEAT MOTOR RISER CHAIRS LTD.
K781614 10/03/1978 MOTOR RISER TOLIT LIFT MOTOR RISER CHAIRS LTD.
K780458 10/10/1978 TRANSCUTANEOUS OXYGEN PERFUSION MONITOR NARCO AIR-SHIELDS
K781615 10/11/1978 NASOSTAT NASOSTAT, INC.
K780988 10/03/1978 DEVIN-NESTOR PNEUMATIC TOURNIQUET NESTOR ENGINEERING ASSOCIATES, INC.
K780989 10/03/1978 DEVIN-NESTOR SQUARE KNIFE NESTOR ENGINEERING ASSOCIATES, INC.
K780991 10/03/1978 PARALLEL BLADE MARKER NESTOR ENGINEERING ASSOCIATES, INC.
K780990 10/03/1978 STAINLESS STEEL TEMPLATE NESTOR ENGINEERING ASSOCIATES, INC.
K781560 10/17/1978 RIA DIAG. TEST KIT FOR INDEXING THYROX. NUCLEAR DIAGNOSTICS, INC.
K781554 10/11/1978 RAD-291 ORGANON, INC.
K781573 10/17/1978 ABNORMAL HEMATOLOGY CONTROL UNASSAYED ORTHO DIAGNOSTICS, INC.
K781572 10/17/1978 NORMAL HEMATOLOGY CONTROL UNASSAYED ORTHO DIAGNOSTICS, INC.
K781663 10/10/1978 HEARING AID, ITE MODULAR MODEL I, II, V OTICON CORP.
K781115 10/06/1978 PRINTER, DIGITAL OUTPUT, INC.
K781776 10/27/1978 PACING LEADS MODEL UL-811 AND UL-813 PACESETTER SYSTEMS
K781297 10/25/1978 INTRA-ALERT PAN-TECH RESEARCH, INC.
K781506 10/17/1978 MIC-BIO-PLATE PASCO LABORATORIES, INC.
K781680 10/06/1978 MONITORING, PRESSURE KIT PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781709 10/24/1978 SCANNER, LINEAR PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781156 10/24/1978 DIALYSIS SYS., PDS 400 & RO 400 PHYSIO-CONTROL CORP.
K780958 10/24/1978 MUELLER HINTON AGAR WITH 5% SHEEP BLOOD PITTSBURGH MICRO-MEDIA, INC.
K780959 10/24/1978 MUELLER HINTON AGAR WITH THYMIDINE PITTSBURGH MICRO-MEDIA, INC.
K781224 10/15/1978 METER, FLOW, PEAK PROJECTS IN HEALTH
K781636 10/11/1978 C.P.R. COUNTING PACER QUAL-TEC, INC.
K781487 10/11/1978 EARLY PREGNANCY DETECTION KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K781605 10/10/1978 R&R ABSORBENT POINTS RANSOM AND RANDOLPH
K781271 10/12/1978 MONITOR, PO2, INTRAVASCULAR ROCHE MEDICAL ELECTRONICS, INC.
K781557 10/17/1978 24-HOUR URINE COLLECTION COOLING WRAP SAGE PRODUCTS, INC.
K781489 10/03/1978 ACID PHOSPHATASE DIAG. KIT SCLAVO, INC.
K781459 10/24/1978 MONOJECT SCALE MAGNIFIER SHERWOOD MEDICAL INDUSTRIES
K781639 10/24/1978 SHILEY CRICOTHYROTOMY TUBE SHILEY, INC.
K781711 10/24/1978 EVALUSKOP SIEMENS CORP.
K781705 10/24/1978 MOBIL XR SIEMENS CORP.
K781613 10/03/1978 SIREMAT SIEMENS CORP.
K781543 10/24/1978 ORBIOGRAPH SONOMETRICS SYSTEMS, INC.
K781552 10/26/1978 MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2 SORENSEN RESEARCH
K781553 10/26/1978 MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 SORENSEN RESEARCH
K781550 10/26/1978 TRAUMA DRAINAGE SET 72T-28TTC SORENSEN RESEARCH
K781551 10/26/1978 TRAUMA DRAINAGE SET 72T-32TTC SORENSEN RESEARCH
K781453 10/24/1978 MODEL 770 ARGON LASER SPECTRA-PHYSICS, INC.
K781635 10/03/1978 CHLORIDE TEST SET, CAT.# 0210 STANBIO LABORATORY
K781565 10/11/1978 ELECTRICAL NERVE STIMULATOR MODEL 6035 STIMULATION TECHNOLOGY, INC.
K781601 10/10/1978 TEKNI-CAL STRECK LABORATORIES, INC.
K781707 10/26/1978 FILTER, ARTERIAL BLOOD W/TUBING BYPASS SURGIKOS, INC.
K781717 10/27/1978 MONITOR, GRAVITY IRRIGATION DRIP SYNTEL, INC.
K781378 10/10/1978 EMIT N-ACETYLPROCAINAMIDE ASSAY SYVA CO.
K781382 10/17/1978 EMIT PROCAINAMIDE ASSAY SYVA CO.
K781647 10/17/1978 BACK TRAC TECH ENGINEERING, INC.
K781533 10/03/1978 SMA/GGT TECHNICON INSTRUMENTS CORP.
K781598 10/17/1978 TECHNICON AUTOSLIDE STAINING/PROCESSING TECHNICON INSTRUMENTS CORP.
K780478 10/02/1978 LIQUID CRYSTAL THERMOGRAPHIC SYSTEM THERMAL IMAGERY, INC.
K781697 10/27/1978 PRESSURE, LOW/HIGH MODEL C1070 TIMETER INSTRUMENT CORP.
K781729 10/24/1978 TRACHEOTOMY TUBES TRACOE MEDICAL GMBH
K781510 10/24/1978 DISPOSABLE LECTROSWITCH, MODEL E2503 VALLEYLAB, INC.
K781511 10/24/1978 LECTROSWITCH MODEL E2502B VALLEYLAB, INC.
K781518 10/06/1978 PREGELLED DISPOSABLE ELECTRODE VENTE MEDICAL PRODUCTS, INC.
K781430 10/31/1978 PREGELLED DISPOSABLE E.K.G. ELECTRODE VERMONT MEDICAL, INC.
K781332 10/04/1978 PEEP/CPAP VALVE VICKERS AMERICA MEDICAL CORP.
K781629 10/27/1978 SERI-SEP SERUM/PLASMA ISLOLATOR WAKO INTL., INC.
K781735 10/24/1978 ENDOPROSTHESIS SYSTEM, VARIO-HEAD WALDEMAR LINK GMBH & CO. KG
K781599 10/17/1978 I-ESTRIOL TEST SET WIEN LABORATORIES, INC.
K781529 10/17/1978 SEPTAL BUTTON XOMED, INC.
K781520 10/10/1978 RUBBER DAM HOLDER YOUNG DENTAL MANUFACTURING CO 1, LLC.


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