FJG — Dialyzer, Parallel Flow Class II
FDA product code FJG covers "Dialyzer, Parallel Flow", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- FJG
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933681 | Cobe Renal Care | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | Sep 7, 1994 |
| K933680 | Cobe Renal Care | GAMBRO LUNDIA PRO 200 DIALYZER | Aug 26, 1994 |
| K920693 | National Medical Care, Medical Products Div | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | Sep 21, 1992 |
| K915504 | C.G.H. Medical | GAMBRO LUNDIA ALPHA HEMODIALYZERS | Mar 6, 1992 |
| K901368 | Gambro-Hospal | HEMOSPAL KITS A1, A2D, AO, & A1D | Aug 2, 1990 |
| K902203 | Akcess Medical Products | TENCKHOFF PERITONEAL DIALYSIS KIT | Aug 1, 1990 |
| K862840 | Gambro | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N | Sep 29, 1986 |
| K853406 | Gambro | GAMBRO LUNDIA PRO 3 & 5 DIALYZER | Jan 8, 1986 |
| K820694 | Cobe Laboratories | COBE PPD 1.3L, #18-520-009 | Mar 31, 1982 |
| K812336 | Cobe Laboratories | COBE PPD 1.9 | Aug 31, 1981 |
| K811440 | Extracorporeal Medical Specialities | EXP 600 PARALLEL PLATE DIALYZER | Jun 12, 1981 |
| K811439 | Extracorporeal Medical Specialities | EXP 200 PARALLEL PLATE DIALYZER | Jun 12, 1981 |
| K810066 | Cobe Laboratories | COBE PPD .8 | Jun 9, 1981 |
| K810837 | Cyberex | CYBER 80 HEMODIALYZER | May 5, 1981 |
| K802478 | Cyberex | CYBER 120 HEMODIALYZER | Mar 20, 1981 |
| K803068 | Nikkiso Co | NIKKISO ND-14 PARALLEL FLOW DIALYZER | Mar 4, 1981 |
| K802364 | Extracorporeal Medical Specialities | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE | Jan 29, 1981 |
| K802389 | Gambro | GAMBRO LUNDIA PLATE DISP. DIALYZER | Dec 22, 1980 |
| K801633 | Bellco Artifidial Organ Spec | THE BRAVO NEW PARALLEL FLOW DIALYZER | Dec 18, 1980 |
| K801451 | Medical | ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM | Sep 26, 1980 |