K892523 is an FDA 510(k) clearance for the GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY. 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 May 11, 1989, 30 days after receiving the submission on April 11, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K892523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1989 |
| Decision Date | May 11, 1989 |
| Days to Decision | 30 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 |