Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 40
- Latest Decision
- 1980-08-13
Clearances · page 151 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K801614 | MODEL 40-30-2 AIR ELIMINATING FILTER SET | Y | FPB | Class II | 1980-08-13 |
| K801704 | OPEN-LOOP INSULIN DELIVERY SYSTEM | Delta Medical Industries | FRN | Class II | 1980-08-13 |
| K801821 | FLOW MED 150 | D.R.O. Medical, Inc. | FPA | Class II | 1980-08-13 |
| K801428 | CHEMDI | American Sterilizer Co. | JOJ | Class II | 1980-08-13 |
| K801725 | KANGAROO ENTERAL FEEDING PUMP | Chesebrough-Pond'S U.S.A. Co. | FRN | Class II | 1980-08-13 |
| K801414 | ERYTHROCATH INTRAVENOUS CATHETER PLA. U. | G.D. Searle and Co. | FOZ | Class II | 1980-08-13 |
| K801613 | MODEL 72-81-0 UNVENTED SOLUTION ADM. SET | Y | FPA | Class II | 1980-08-12 |
| K801605 | BIMECO FILTERED EXTENSION SET | Burron Medical Products, Inc. | FPB | Class II | 1980-08-12 |
| K801540 | MCGRAW I.V. ADMINISTRATION SET | American Hospital Supply Corp. | FPA | Class II | 1980-08-12 |
| K801431 | PAN-AM MYELOGRAM TRAY | Waters Assoc., Inc. | FMI | Class II | 1980-08-12 |
| K801441 | ABBOTT/SHAW LIFE CARE PUMP MODEL 3 | Abbott Laboratories | FRN | Class II | 1980-08-12 |
| K801458 | WINTER HEAD DRESSING | Steridyne Corp. | FQM | Class I | 1980-07-28 |
| K801461 | THERMA-SHIELD | Olympic Medical Corp. | FMZ | Class II | 1980-07-28 |
| K801169 | OHIO FREE FLOW VACUUM REGULATOR | Ohio Medical Products | KDP | Class II | 1980-07-28 |
| K801569 | VAL-U-WRAP CSR WRAP | American Convertors Div., American Pharmaseal | FRG | Class II | 1980-07-28 |
| K801421 | TUBE HOLDER | Devon Industries, Inc. | LDQ | 1980-07-28 | |
| K801532 | STOCKINETTE, STERILE TWO PLY W/PULL TABS | The Owenby Co. | FQM | Class I | 1980-07-28 |
| K801366 | DISPOSABLE TEMPERATURE PROBE COVER | Bib, Inc. | FLL | Class II | 1980-07-28 |
| K801445 | SKIN STAPLER HANDLE 523700/CARTRIDGES | Edward Weck, Inc. | GAG | Class II | 1980-07-14 |
| K800627 | AMBULATORY INFUSION PUMP, CODE 2M9807 | Travenol Laboratories, S.A. | FRN | Class II | 1980-07-14 |
| K801430 | CONTROL SYRINGE | Abco Dealers, Inc. | FMF | Class II | 1980-07-08 |
| K801332 | AMPCO SKIN SCRUB TRAYS | Associated Medical Products Co. | FRG | Class II | 1980-06-20 |
| K801343 | B-D FILTER NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | FPB | Class II | 1980-06-20 |
| K801309 | RITTER STERILIZER | Sybron Corp. | FLE | Class II | 1980-06-20 |
| K800879 | CLEAR PLASTIC CONNECTING TUBES | Harvard Laboratories | FPK | Class II | 1980-06-17 |
| K801272 | TECNOL QUICK RELEASE LIMB HOLDER | Tecnol New Jersey Wound Care, Inc. | FMQ | Class I | 1980-06-17 |
| K800877 | ANESTHESIA EXTENSION TUBES | Harvard Laboratories | FPK | Class II | 1980-06-17 |
| K801311 | BURRON MULTI-AD SYRINGE CAP | Burron Medical Products, Inc. | FMF | Class II | 1980-06-17 |
| K801057 | 3M STEAM STERILIZATION INDICATOR | 3M Company | JOJ | Class II | 1980-06-17 |
| K800878 | SECONDARY I.V. TUBING SETS | Harvard Laboratories | FPA | Class II | 1980-06-17 |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Stock Wild & Co. | FMP | Class I | 1980-06-09 |
| K801259 | NEEDLE COUNTER-SURE COUNT/100 COUNT | Kleen Test Products | MMK | Class II | 1980-06-09 |
| K801221 | THORA-DRAIN III PLASTIC DRAINAGE SYSTEM | Chesebrough-Pond'S U.S.A. Co. | KDQ | Class II | 1980-06-09 |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Burron Medical Products, Inc. | KYX | Class I | 1980-06-02 |
| K800862 | 1,3 & 4 WAY STERILE DIS. PLASTIC PKG. | Custom Medical Devices Intl., Inc. | FMG | Class II | 1980-05-30 |
| K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | Burron Medical Products, Inc. | FMI | Class II | 1980-05-30 |
| K801179 | FLOW MED 160 | D.R.O. Medical, Inc. | FPA | Class II | 1980-05-30 |
| K791328 | ALLER-SCREEN SKIN TEST KIT | Aller-Screen, Inc. | SCL | Class II | 1980-05-30 |
| K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | Burron Medical Products, Inc. | FMI | Class II | 1980-05-30 |
| K801134 | MICROVAC | Progress Mankind Technology | JOL | Class II | 1980-05-30 |
| K800863 | TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS | Custom Medical Devices Intl., Inc. | FMG | Class II | 1980-05-30 |
| K801109 | PROOF (BIOLOGICAL/CHEMICAL INDICATOR) | Amsco Co. | JOJ | Class II | 1980-05-30 |
| K800864 | STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE | Custom Medical Devices Intl., Inc. | FMG | Class II | 1980-05-30 |
| K801127 | MACROVAC | Progress Mankind Technology | JOL | Class II | 1980-05-30 |
| K800907 | TOMAC WET DRESSING WARMER | W.G. Whitney Corp. | KGX | Class I | 1980-05-20 |
| K800629 | INTRAVENOUS INFUSION PUMP, CODE 2M8015 | Travenol Laboratories, S.A. | FRN | Class II | 1980-05-14 |
| K800825 | EXTENSION SET QUEST CODE #3000 | Quest Medical, Inc. | FPK | Class II | 1980-05-14 |
| K800786 | INJECTION SITE, CODE NO. 3100 | Quest Medical, Inc. | FOZ | Class II | 1980-05-08 |
| K800711 | VOLUMETRIC PUMP CASSETTE W/ATTACHED SET | Travenol Laboratories, S.A. | FPA | Class II | 1980-05-08 |
| K800726 | EYEWI ANKORS | Eyevi & Co. | KMK | Class I | 1980-05-08 |
| K800638 | PLASMA PRODUCTS CO. NON-VENTED INTRA/SET | Plasma Products Co. | FPA | Class II | 1980-05-08 |
| K800849 | TMS 1000 TEMP. MONITOR & PROBES | Gics Pharmaceuticals | FLL | Class II | 1980-05-08 |
| K800067 | VITA LAMP, MODEL 0350 | Tensor Industries, Inc. | KZF | Class I | 1980-05-08 |
| K800873 | TIME STEAM AUTOCLAVE TAPE | Professional Tape Co., Inc. | JOJ | Class II | 1980-05-08 |
| K800637 | PLASMA PRODUCTS CO., INTRA/ADMIN/SET- | Plasma Products Co. | FPA | Class II | 1980-05-08 |
| K800527 | CLINIGUARD | Clinipad Corp. | KMF | Class I | 1980-05-08 |
| K800861 | SNYDER HEMOVAC CHEST DRAINAGE SOLUTION | Snyder Laboratories, Inc. | KDQ | Class II | 1980-05-02 |
| K801004 | FLOW MED 160 | D.R.O. Medical, Inc. | FPA | Class II | 1980-05-02 |
| K800440 | STERILE SPONGE BOWLS | Premium Plastics, Inc. | FNY | Class I | 1980-04-29 |
| K800560 | MX820-5 PRESSURE INFUSOR 500CC MX820-10 | Medex, Inc. | KZD | Class I | 1980-04-29 |
| K800482 | STEAROTHERMOHILUS SPORE STRIPS | Mdt Corp., Inc. | FRC | Class II | 1980-04-16 |
| K800570 | HEPARIN PUMP #7420 | Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN | Class II | 1980-04-16 |
| K800358 | Y-TYPE INFUSION SET (2 LEAD) | Haemonetics Corp. | FPA | Class II | 1980-04-16 |
| K800600 | B-D STASET, I.V. FLOW CONTROLLER | Bd Becton Dickinson Vacutainer Systems Preanalytic | FPA | Class II | 1980-04-16 |
| K800403 | MCGAW/EPIC I.V. ADMIN. SET | American Hospital Supply Corp. | FPA | Class II | 1980-04-16 |
| K800635 | C.C.-PAK | Respiratory Care, Inc. | JOL | Class II | 1980-04-10 |
| K800569 | SYRINGE INFUSION PUMP #2720 | Harvard Apparatus, Inc. | FRN | Class II | 1980-04-08 |
| K800525 | MEDICAL COMPONENTS IV CATHETER | Medical Components, Inc. | FOZ | Class II | 1980-04-08 |
| K791496 | LOW PLASTICIZER ADMINISTRATION SETS | Travenol Laboratories, S.A. | FPA | Class II | 1980-04-08 |
| K800064 | WATER JEL FIRE BLANKET | Trilling Resources, Ltd. | FPY | Class I | 1980-03-25 |
| K800512 | ELECTRONIC CLINICAL THERM. MODEL 811A | Y | FLL | Class II | 1980-03-25 |
| K800396 | STAT TEMP MODEL 4800 | Baessler Medical Electronics,Inc. | FLL | Class II | 1980-03-25 |
| K800137 | PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN | Abbott Laboratories | FPA | Class II | 1980-03-20 |
| K800373 | TENDERLIFT | Competent Design | FMR | Class I | 1980-03-12 |
| K800437 | SYRINGE TIP CONNECTOR | Burron Medical Products, Inc. | KYX | Class I | 1980-03-12 |
| K800280 | MEDSPEC RUBBER ELASTIC BANDAGES | Medspec Corp. | FQM | Class I | 1980-03-12 |
| K800029 | SURGICOT 2 INDICATOR SYSTEM | Surgicot, Inc. | FRC | Class II | 1980-03-12 |
| K800277 | MEDSPEC RAYON BALLS | Medspec Corp. | FRL | Class I | 1980-03-12 |
| K800362 | FLUID DISPENSING SYSTEM | Pharmaseal Laboratories | KYX | Class I | 1980-03-12 |
| K792050 | 3M SMALL VOLUME INFUSTION (SVI) SYSTEM | 3M Company | FRN | Class II | 1980-03-10 |
| K792725 | FIXOMULL | Beiersdorf, Inc. | FPX | Class I | 1980-03-05 |
| K792726 | LEUKOFIX POROS | Beiersdorf, Inc. | FPX | Class I | 1980-02-28 |
| K800197 | ANAGO DISP., ALL PURPOSE PATIENT REST. | Anago, Inc. | FQM | Class I | 1980-02-26 |
| K792501 | PLS MINI | Staodynamics, Inc. | BWJ | Class II | 1980-02-26 |
| K792529 | POINT LOCATOR STIMULATOR | Staodynamics, Inc. | BWJ | Class II | 1980-02-26 |
| K800213 | PHARMACY ADDITIVE SYRINGE SET | Cutter Laboratories, Inc. | KYW | Class I | 1980-02-26 |
| K800231 | ABCO/GRANT ALTERNATING PRESSURE PAD & UT | Abco Dealers, Inc. | FNM | Class II | 1980-02-26 |
| K800284 | THREE-WAY STOPCOCK EXTENSION SET 20-SL | Abbott Laboratories | FMG | Class II | 1980-02-26 |
| K800234 | ABCO SUCTION CATHETER & KITS W/GLOVE&CUP | Abco Dealers, Inc. | JOL | Class II | 1980-02-26 |
| K800235 | ABCO CONNECTING TUBES PRECUT LENGTHS | Abco Dealers, Inc. | BYY | Class II | 1980-02-26 |
| K800230 | ABCO EXAMINATION LAMP (GOOSENECK TYPE) | Abco Dealers, Inc. | KZF | Class I | 1980-02-26 |
| K800248 | SURGITEK FOERSTER FACE LIFT BANDAGE | Medical Engineering Corp. | FRL | Class I | 1980-02-19 |
| K800249 | SURGITEK FOERSTER MAMMARY BANDAGE | Medical Engineering Corp. | FRL | Class I | 1980-02-19 |
| K800123 | DEXTEX II STERILIZATION WRAP | Ahlstrom Dexter | FRG | Class II | 1980-02-13 |
| K792520 | ANESTHESIA & HOSPITAL SYRINGE HOLDER | Medical Innovations Corp. | FMF | Class II | 1980-02-07 |
| K792648 | UNILAB CULTURING SET | Sybron Corp. | FRC | Class II | 1980-02-06 |
| K791798 | CONPHAR SURGICAL RAZORR | Conphar, Inc. | LDQ | 1980-02-01 | |
| K792660 | 1500 EO EXHAUST HOOD | Castle Co. | FLF | Class II | 1980-01-29 |
| K792649 | UNISPORE-BIOLOGICAL INDICATORS | Castle Co. | FRC | Class II | 1980-01-29 |
| K800024 | I.V. TAPE DOWN HOLDER | Consolidated Medical Equipment, Inc. | KMK | Class I | 1980-01-29 |
15,723 clearances in the General Hospital panel. Data: openFDA.