FDA 510(k) Applications Received During September, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K760611 09/10/1976 3M BRAND ANESTHESIA FILTER,#3110 3M COMPANY
K760694 09/22/1976 ARNCO I.V. MONITOR A.R. NELSON CO., INC.
K760721 09/27/1976 MEDICAL OSCILLOSCOPE MEMORY SCOPE ABBOTT LABORATORIES
K760593 09/07/1976 PORTABLE CARDIAC MONITOR, ABBY ABBOTT LABORATORIES
K760655 09/16/1976 ANEROID SPHYGMOMANOMETER ABCO DEALERS, INC.
K760703 09/23/1976 SPONGE AND GAUZE FORCEP PART #S-417-9 ACME UNITED CORP.
K760663 09/17/1976 MVP-10 PEDIATRIC/NEONATAL VENTILATOR AIR-SHIELDS, INC.
K760697 09/22/1976 EVANS ARM AND HAND REST ALCON LABORATORIES
K760696 09/22/1976 REMOTE CONTROL SYSTEM FOR MICROSCOPE ALCON LABORATORIES
K760667 09/17/1976 4-WAY STOPCOCK W/10 CM EXTEN. TUBING AMERICAN VIGGO
K760678 09/20/1976 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK AMERICAN VIGGO
K760679 09/20/1976 4-WAY STOPCOCK W/7CM TUBING, AMERICAN VIGGO
K760666 09/17/1976 4-WAY STOPCOCK W/LUER-LOCK FITTING AMERICAN VIGGO
K760592 09/07/1976 MINICON CONCENTRATOR AMICON, INC.
K760642 09/14/1976 ANALYZER, PROGRAMMABLE DISCRETE (PDA) ANATRONICS CORP.
K760675 09/17/1976 ELECTROSURGICAL DISPERSIVE PLATE ASPEN LABORATORIES, INC.
K760680 09/20/1976 INTERMITTENT MANDATORY VENTILATION B & F MEDICAL PRODUCTS, INC.
K760689 09/21/1976 NERVEL-NERVE CONDUCTION VELOCITY METER BAK ELECTRONICS
K760583 09/03/1976 DISPOSABLE/BOROSILICATE CULTURE TUBES BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760582 09/03/1976 HA/3 HEMATOLOGY ANALYZER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760581 09/03/1976 HA/5 HEMATOLOGY ANALYZER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760588 09/03/1976 IMPROVED THAYER MARTIN MEDIUM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760641 09/14/1976 MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760643 09/14/1976 MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760586 09/03/1976 SUCTION KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760701 09/22/1976 SULFACYTINE 0.25 MG. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760587 09/03/1976 U-MID PREFILLED HUMIDIFIER (300CC) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760584 09/03/1976 U-MID PREFILLED HUMIDIFIER (500CC) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760585 09/03/1976 U-MID PREFILLED NEBULIZER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760589 09/03/1976 VCA INHIBITOR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760730 09/27/1976 ANTICONVULSANT CONTROL SERUM BIO-REAGENTS & DIAGNOSTICS, INC.
K760722 09/27/1976 BIRT-A-CHUCK DISPOSABLE ELECTR. HANDLE BIRTCHER CORP.
K760596 09/07/1976 BIOTROL-ABNORMAL BOEHRINGER MANNHEIM CORP.
K760597 09/07/1976 BIOTROL-NORMAL BOEHRINGER MANNHEIM CORP.
K760713 09/24/1976 TRIGLYCERIDES TEST BOEHRINGER MANNHEIM CORP.
K760736 09/28/1976 BARIMEX, BARIUM SULFATE COMPOUND C.R. BARD, INC.
K760662 09/17/1976 STERIL.WRAP(#221901,2,3,4,5,6,7,8,9) C.R. BARD, INC.
K760661 09/17/1976 STERILIZER WRAP (CAT#221831,2,3,4,5,6) C.R. BARD, INC.
K760600 09/07/1976 CARDIAC OUTPUT COMPUTER CARDIOPULMONARY INSTRUMENTATION
K760599 09/07/1976 DENTAL CHAIRS CHAYES VIRGINIA, INC.
K760665 09/17/1976 FISTULA NEEDLE (#11-265) COBE LABORATORIES, INC.
K760624 09/13/1976 SMALL VESSEL CANNULA COBE LABORATORIES, INC.
K760746 09/30/1976 YASARGIL SUCTION TUBE - LARGE CODMAN & SHURTLEFF, INC.
K760747 09/30/1976 YASARGIL SUCTION TUBE - MEDIUM CODMAN & SHURTLEFF, INC.
K760745 09/30/1976 YASARGIL SUCTION TUBE - SMALL CODMAN & SHURTLEFF, INC.
K760714 09/25/1976 ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. CORATOMIC, INC.
K760788 09/10/1976 PH METER-125 (.01 PH) CORNING MEDICAL & SCIENTIFIC
K760789 09/10/1976 PH METER-130 (.001 PH) CORNING MEDICAL & SCIENTIFIC
K760682 09/20/1976 4C ABNORMAL LOW-HIGH (8 X 6 M1) COULTER ELECTRONICS, INC.
K760664 09/17/1976 CRAWFORD PORTAVAC CRAWFORD ELECTRIC
K760686 09/20/1976 CRYOLYZER ALPHA (CRYOSURG.EQUIP.) CRYO-LABS, INC.
K760744 09/30/1976 TAVERNETTI-TENNANT CUTTER LABORATORIES, INC.
K760594 09/07/1976 AUTO-FI COAGULATION INSTRUMENT DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760719 09/27/1976 UNIFORM DROP SIZE PASTEUR TYPE PIPETS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760649 09/15/1976 TOTAL SPINAL CORRECTION DEPUY, INC.
K760636 09/13/1976 ORTHOMIX DIEMOLDING CORP.
K760650 09/15/1976 RETRACTOR, GERBODE STERNAL DILLING CO.
K760700 09/22/1976 SILASTIC BRAND G7-2090A DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760708 09/25/1976 SILASTIC BRAND Q7-2091 GASTRIC SUMP TUBE DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760571 09/02/1976 FLOSS-A-LOT E. T. SKINNER
K760739 09/29/1976 ACA DATA MATE ACCESSORY E.I. DUPONT DE NEMOURS & CO., INC.
K760634 09/13/1976 ACA PHOSPHORUS ANALYTICAL TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K760602 09/07/1976 SORVALL EMBEDDING MEDIUM E.I. DUPONT DE NEMOURS & CO., INC.
K760618 09/13/1976 PATIENT RESTRAINT ENCOMPASS GROUP, LLC.
K760702 09/22/1976 ERI-FLO 900 DIALYZER ERIKA, INC.
K760734 09/28/1976 REGULAR AND WIDE SKIN STAPLES ETHICON, INC.
K760733 09/28/1976 SKIN STAPLE EXTRACTOR ETHICON, INC.
K760732 09/28/1976 SKIN STAPLING INSTRUMENT ETHICON, INC.
K760604 09/08/1976 EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS. EUREKA X-RAY TUBE CORP.
K760718 09/25/1976 PERISTALTIC INFUSION PUMP (2100,2101) EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K760606 09/09/1976 HA ANTIGEN FLOW LABORATORIES, INC.
K760607 09/09/1976 HI CHICKEN ANTISERUM FLOW LABORATORIES, INC.
K760608 09/09/1976 HI CHICKEN PRESERUM FLOW LABORATORIES, INC.
K760692 09/21/1976 MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN FLOW LABORATORIES, INC.
K760693 09/21/1976 NEIGON JEMBEC PLATE WITH ANIXOMYCIN FLOW LABORATORIES, INC.
K760691 09/21/1976 THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L FLOW LABORATORIES, INC.
K760690 09/21/1976 THAYER-MARTIN MEDIUM WITH ANSIOMYCIN FLOW LABORATORIES, INC.
K760567 09/02/1976 BACTERIA FILTER FOREGGER AIR PRODUCTS & CHEM., INC.
K760566 09/02/1976 PREFILLED HUMIDIFIER FOREGGER AIR PRODUCTS & CHEM., INC.
K760565 09/02/1976 VENTILATOR CIRCUITS FOREGGER AIR PRODUCTS & CHEM., INC.
K760742 09/30/1976 CS-76 AND/OR CRYOCARE I FRIGITRONICS OF CONNECTICUT, INC.
K760595 09/07/1976 CARDIAC PROBE G.D. SEARLE AND CO.
K760725 09/27/1976 COIL MACHINE ADAPTER GAMBRO, INC.
K760706 09/23/1976 MUL-T-PAD GAYMAR INDUSTRIES, INC.
K760688 09/20/1976 CT/N-II SCANNER SYSTEM GENERAL ELECTRIC CO.
K760559 09/02/1976 PATIENT MONITORING SYSTEM GENERAL ELECTRIC CO.
K760749 09/30/1976 SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY GILFORD INSTRUMENT LABORATORIES, INC.
K760644 09/15/1976 NECKSAVER HEALTH SAVER CORP.
K760673 09/20/1976 RAPI/TEX-LGM KIT HOECHST-ROUSSEL PHARMACEUTICALS, INC.
K760735 09/28/1976 BONGORT "SPECIAL" ODORPROOF DRAIN HOWMEDICA CORP.
K760712 09/24/1976 MEDISCUS AIR BED HSI PRODUCTS, INC.
K760720 09/27/1976 MON-A-THERM TEMPARATURE MONITOR SYS LABARGE, INC.
K760743 09/30/1976 DONORMATIC (BLOOD COLLECTION DEVICE) LIFELINE INSTRUMENTS, INC.
K760699 09/22/1976 MULTI-TEST LINCOLN LABORATORIES, INC.
K760568 09/02/1976 SINGLE PHASE X-RAY CONTROLS & HV GENERATORS LITTON MEDICAL SYSTEMS
K760569 09/02/1976 THREE PHASE X-RAY CONTROLS & HV GENERATORS LITTON MEDICAL SYSTEMS
K760620 09/13/1976 SALIVA EJECTOR LORVIC CORP.
K760674 09/16/1976 SYN-O-SCOPE NASAL INHALER MCDONALD AND ASSOC., INC.
K760635 09/13/1976 MEDI-DYNE APNEA MONITOR MED DYNE INST., INC.
K760738 09/28/1976 AUTOMATIC ELECTRONIC SPHYGMOMANOMETER MEDICAL MONITORS, INC.
K760562 09/02/1976 CHIN IMPLANTS MEDIPLAST LABORATORIES, INC.
K760668 09/17/1976 SELECTATEC SYSTEM MEDISHIELD, INC.
K760613 09/10/1976 FLOTATION UNIT, CHAIR MEDPRO, INC.
K760728 09/27/1976 CONTINUOUS WAVE DOPPLER ULTRASOUND MEDSONICS
K760605 09/08/1976 LIGHTCAST II CARBIDE BLADE MERCK, SHARP & DOHME
K760572 09/02/1976 SERALUTE MILES LABORATORIES, INC.
K760741 09/30/1976 PORTABLE X-RAY MINXRAY, INC.
K760656 09/15/1976 DETARTRINE Z MR. J. GARRICK EISENBERG
K760619 09/13/1976 RADIO IMMUNO ASSAY KIT/ NEW ENGLAND NUCLEAR
K760580 09/03/1976 DRUG NEBULIZER OHIO MEDICAL PRODUCTS
K760651 09/15/1976 TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL ORTHOPEDIC EQUIPMENT CO., INC.
K760614 09/10/1976 PERIPHERAL NERVE STIMULATOR OUTPUT, INC.
K760578 09/03/1976 BALANCED CAST SOLE PARKE-DAVIS CO.
K760723 09/27/1976 SAFE-T-PINS RETENTIVE PIN SYSTEM PARKELL, INC.
K760564 09/02/1976 DEMODULATOR SERIES 1400 PHYSIO-CONTROL CORP.
K760563 09/02/1976 ECG MODULATOR PHYSIO-CONTROL CORP.
K760677 09/20/1976 LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5) PHYSIO-CONTROL CORP.
K760676 09/20/1976 LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE PHYSIO-CONTROL CORP.
K760724 09/27/1976 PERITONEAL DIALYSIS SYSTEM PHYSIO-CONTROL CORP.
K760647 09/15/1976 ADAPTER, FIBER OPTICS HEADLIGHT PILLING CO.
K760653 09/16/1976 ADAPTER/STANDARD FIBER OPTICS LIGHT PILLING CO.
K760645 09/15/1976 CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP PILLING CO.
K760646 09/15/1976 CAROTID ARTERY CLAMP W/PILLING LMM PILLING CO.
K760652 09/15/1976 JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S PILLING CO.
K760654 09/16/1976 MULTI-PORTED FACE PLATE PILLING CO.
K760648 09/15/1976 TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS PILLING CO.
K760683 09/20/1976 ALARM, THERMAL, THERM-ALERT RESPIRATORY CARE, INC.
K760574 09/03/1976 ECONOMY IMMOBILIZATION AND VELPEAN SLING RICHARD'S MEDICAL EQUIP., INC.
K760573 09/03/1976 IMPROVED KNEE DRESSING RICHARD'S MEDICAL EQUIP., INC.
K760577 09/03/1976 RICHARDS CLAVICLE STRAP RICHARD'S MEDICAL EQUIP., INC.
K760575 09/03/1976 ROCKER-SOLE CAST SANDAL RICHARD'S MEDICAL EQUIP., INC.
K760576 09/03/1976 TOURNIWRAP BANDAGE RICHARD'S MEDICAL EQUIP., INC.
K760707 09/23/1976 RITTER STARLIGHT DENTAL OPERATING LIGHT RITTER CO.
K760598 09/07/1976 IMPROVED THAYER MARTIN MEDIUM SCOTT LABORATORIES, INC.
K760659 09/15/1976 CALCIPULPE SEPTODONT, INC.
K760658 09/15/1976 DETARTRINE P SEPTODONT, INC.
K760660 09/15/1976 HYDROL SEPTODONT, INC.
K760657 09/15/1976 RACESTYPTINE CORD SEPTODONT, INC.
K761024 09/15/1976 RACESTYPTINE RINGS SEPTODONT, INC.
K760601 09/07/1976 ARGYLE SUCTION CONTROL KIT SHERWOOD MEDICAL CO.
K760556 09/01/1976 IRRIGATION CATHETER SHERWOOD MEDICAL INDUSTRIES
K760622 09/13/1976 LANCER AUTOANALYZER MANIFOLD PUMP TUB SHERWOOD MEDICAL INDUSTRIES
K760623 09/13/1976 LANCER PARAPLAST HISTO PROCESS CASSETTE SHERWOOD MEDICAL INDUSTRIES
K760621 09/13/1976 LANCER PLASTIC TRANSFER PIPETTE SHERWOOD MEDICAL INDUSTRIES
K760711 09/25/1976 REAGENT SYSTEM (NO. SC 135) SIGMA CHEMICAL CO.
K760685 09/20/1976 SIGMA PROCED #SC165 SIGMA CHEMICAL CO.
K760591 09/07/1976 SIGMA PROCEDURE NO. 745 - EP.REAGENT SY SIGMA CHEMICAL CO.
K760631 09/13/1976 FILTER SET 1288 SORENSEN RESEARCH
K760629 09/13/1976 FILTER SET PMF 100 SORENSEN RESEARCH
K760633 09/13/1976 FILTER SET PMF 1028 SORENSEN RESEARCH
K760625 09/13/1976 FILTER SET PMF 1168 SORENSEN RESEARCH
K760630 09/13/1976 FILTER SET PMF 200 SORENSEN RESEARCH
K760632 09/13/1976 FILTER SET PMF 2024 SORENSEN RESEARCH
K760627 09/13/1976 FILTER SET PMF 2168 SORENSEN RESEARCH
K760626 09/13/1976 FILTER SET PMF 2288 SORENSEN RESEARCH
K760628 09/13/1976 FILTER SET PMF 2448 SORENSEN RESEARCH
K760640 09/14/1976 FILTER SET, PMF 1024 SORENSEN RESEARCH
K760637 09/14/1976 FILTER SET, PMF 1448 SORENSEN RESEARCH
K760639 09/14/1976 FILTER SET, PMF 2028 SORENSEN RESEARCH
K760638 09/14/1976 FILTER, PMF 1000 SORENSEN RESEARCH
K760612 09/10/1976 SPACELABS SERIES 1000 SPACELABS, INC.
K760726 09/27/1976 ELECTRO-KERATOTOME, LINE-OPERATED STORZ INSTRUMENT CO.
K760617 09/13/1976 MIX EVAC BONE CEMENT STRYKER CORP.
K760709 09/24/1976 EMIT DIGOKIN ASSAY SYVA CO.
K760672 09/20/1976 CLINICAL SPECTROPHOTOMETER THE DOW CHEMICAL CO.
K760705 09/20/1976 OXYGEN-RICH THE JOHN BUNN CO.
K760737 09/28/1976 SCATTERED TRANSMISSION ACCESSORY THE PERKIN-ELMER CORP.
K760710 09/23/1976 PULSAR PULSE MONITOR WATCH TIME COMPUTER, INC. (TCI)
K760913 09/24/1976 MICROTYNE UNIT TRANSMED, INC.
K760717 09/25/1976 FLEXIBLE BIOPSY FORCEPS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760715 09/25/1976 FLEXIBLE CUTTING SCISSORS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760716 09/25/1976 FLEXIBLE FOREIGN BODY FORCEPS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760579 09/03/1976 INSTRUMENT RACK FOR DAWSON-YUHL INSTR. V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760684 09/20/1976 VISC X-VITREOUS ASPIRATING & CUT. INSTR VARIAN ASSOC., INC.
K760669 09/17/1976 PACEMAKERS, VITATRON'S VITATRON MEDICAL BV
K760670 09/17/1976 PACEMAKERS, VITATRONS (SERIES 2000) VITATRON MEDICAL BV
K760671 09/17/1976 PACEMAKERS, VITATRONS (SERIES 3000) VITATRON MEDICAL BV
K760560 09/02/1976 CATH CARE KIT WALPAK CO.
K760681 09/20/1976 INDIRECT FLUORESCENT (IFA-ANA) WAMPOLE LABORATORIES
K760570 09/01/1976 ROBINSON MIDDLE EAR PROSTHESIS XOMED, INC.
K760704 09/20/1976 OXYGEN-RICH XORBOX
K760695 09/20/1976 TAMARI-KAPLITT YEHUDA TAMARI
K760609 09/09/1976 EYEGLASS HEARING AID ZENITH HEARING INSTRUMENT CO.


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