K002761 is an FDA 510(k) clearance for the FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on December 4, 2000, 90 days after receiving the submission on September 5, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K002761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2000 |
| Decision Date | December 04, 2000 |
| Days to Decision | 90 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 |