K890111 is an FDA 510(k) clearance for the GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER. 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 8, 1989, 28 days after receiving the submission on January 11, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K890111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1989 |
| Decision Date | February 08, 1989 |
| Days to Decision | 28 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 |