PARALLEL PLATE DIALYZER
FDA 510(k) clearance K770578 · decided 1977-04-15
Clearance details
- K-number
- K770578
- Device name
- PARALLEL PLATE DIALYZER
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-28
- Decision date
- 1977-04-15
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- FJG
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (K933681) | Cobe Renal Care, Inc. | 1994-09-07 |
| GAMBRO LUNDIA PRO 200 DIALYZER (K933680) | Cobe Renal Care, Inc. | 1994-08-26 |
| DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (K920693) | National Medical Care, Medical Products Div., Inc. | 1992-09-21 |
| GAMBRO LUNDIA ALPHA HEMODIALYZERS (K915504) | C.G.H. Medical, Inc. | 1992-03-06 |
| HEMOSPAL KITS A1, A2D, AO, & A1D (K901368) | Gambro-Hospal, Inc. | 1990-08-02 |
| TENCKHOFF PERITONEAL DIALYSIS KIT (K902203) | Akcess Medical Products, Inc. | 1990-08-01 |
| GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (K862840) | Gambro, Inc. | 1986-09-29 |
| GAMBRO LUNDIA PRO 3 & 5 DIALYZER (K853406) | Gambro, Inc. | 1986-01-08 |
| COBE PPD 1.3L, #18-520-009 (K820694) | Cobe Laboratories, Inc. | 1982-03-31 |
| COBE PPD 1.9 (K812336) | Cobe Laboratories, Inc. | 1981-08-31 |
| EXP 200 PARALLEL PLATE DIALYZER (K811439) | Extracorporeal Medical Specialities, Inc. | 1981-06-12 |
| EXP 600 PARALLEL PLATE DIALYZER (K811440) | Extracorporeal Medical Specialities, Inc. | 1981-06-12 |
Recalls involving this device
No recalls on record reference this clearance.