K994390 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER, a Hemodialyzer, Re-use, High Flux (Class II — Special Controls, product code MSF), submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on October 26, 2000, 303 days after receiving the submission on December 28, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K994390 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 1999 |
| Decision Date | October 26, 2000 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSF — Hemodialyzer, Re-use, High Flux |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |