K902481 is an FDA 510(k) clearance for the GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by Gambro, Inc. (Williamsburg, US). The FDA issued a Cleared decision on July 27, 1990, 52 days after receiving the submission on June 5, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K902481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1990 |
| Decision Date | July 27, 1990 |
| Days to Decision | 52 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 |