K926005 is an FDA 510(k) clearance for the FRESENIUS HEMOFLOW, VARIOUS MODELS, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on August 23, 1994, 634 days after receiving the submission on November 27, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K926005 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 27, 1992 |
| Decision Date | August 23, 1994 |
| Days to Decision | 634 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |