FDA Product Code
FDA Product Code FJG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | Cobe Renal Care, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K933680 | GAMBRO LUNDIA PRO 200 DIALYZER | Cobe Renal Care, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | National Medical Care, Medical Products Div., Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS | C.G.H. Medical, Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K901368 | HEMOSPAL KITS A1, A2D, AO, & A1D | Gambro-Hospal, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K902203 | TENCKHOFF PERITONEAL DIALYSIS KIT | Akcess Medical Products, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N | Gambro, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER | Gambro, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K820694 | COBE PPD 1.3L, #18-520-009 | Cobe Laboratories, Inc. | 1982-03-31 | Traditional | PDF ↗ |
| K812336 | COBE PPD 1.9 | Cobe Laboratories, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K811440 | EXP 600 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811439 | EXP 200 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K810066 | COBE PPD .8 | Cobe Laboratories, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K810837 | CYBER 80 HEMODIALYZER | Cyberex Corp. | 1981-05-05 | Traditional | PDF ↗ |
| K802478 | CYBER 120 HEMODIALYZER | Cyberex Corp. | 1981-03-20 | Traditional | PDF ↗ |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | NIKKISO CO., LTD. | 1981-03-04 | Traditional | PDF ↗ |
| K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE | Extracorporeal Medical Specialities, Inc. | 1981-01-29 | Traditional | PDF ↗ |
| K802389 | GAMBRO LUNDIA PLATE DISP. DIALYZER | Gambro, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K801633 | THE BRAVO NEW PARALLEL FLOW DIALYZER | Bellco Artifidial Organ Spec., Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K801451 | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM | Medical, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801377 | CYBER 120 HEMODIALYZER | Cyberex Corp. | 1980-08-27 | Traditional | PDF ↗ |
| K800424 | LUNDIA PLATE DISP. | Gambro, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K792611 | GAMBRO LUNDIA PLATE DIALYZER | Gambro, Inc. | 1980-02-06 | Traditional | PDF ↗ |
| K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791448 | HEMODIALYZERS RP-510 AND RP-514 | Hospal Medical Corp. | 1979-08-07 | Traditional | PDF ↗ |
| K790758 | HEMOCLEAR U-NEPHROS 1.0 DIALYZER | Medical, Inc. | 1979-05-08 | Traditional | PDF ↗ |
| K790533 | HD CAPILLARY FILM DIALYZER, MODEL 1001 | Travenol Laboratories, S.A. | 1979-05-02 | Traditional | PDF ↗ |
| K790001 | DIALYZER, MODEL F.M.D 150 | Hospal Medical Corp. | 1979-03-06 | Traditional | PDF ↗ |
| K781966 | DIALYZER, MAGNIFLO 100 PARALLEL PLATE | Erika, Inc. | 1979-02-21 | Traditional | PDF ↗ |
| K781795 | DIALYZER, PARALLEL FLOW DISPOSABLE | Medical, Inc. | 1978-12-15 | Traditional | PDF ↗ |
| K780700 | LUNDIA PLATE DISPOSABLE DIALYZER | Gambro, Inc. | 1978-07-17 | Traditional | PDF ↗ |
| K780427 | RP-510/RP-514 PARALLEL PLATE DIALYZERS | Hospal Medical Corp. | 1978-05-19 | Traditional | PDF ↗ |
| K772318 | DIALYZER STANDARD, CODE 5DM1780 | Travenol Laboratories, S.A. | 1978-01-26 | Traditional | PDF ↗ |
| K771354 | PARALLEL PLATE DIALYZERS | Hospal Medical Corp. | 1977-09-15 | Traditional | PDF ↗ |
| K770858 | DIALYZER, ULTRADIFFUSER, DISPOSABLE | Gambro, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770578 | PARALLEL PLATE DIALYZER | Cobe Laboratories, Inc. | 1977-04-15 | Traditional | PDF ↗ |
Product code FJG · Class II · Gastroenterology, Urology. Data: openFDA.