K880084 is an FDA 510(k) clearance for the GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI).
Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on February 19, 1988, 38 days after receiving the submission on January 12, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K880084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 1988 |
| Decision Date | February 19, 1988 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |