K023615 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR, a Hemodialyzer, Re-use, High Flux (Class II — Special Controls, product code MSF), submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on May 6, 2003, 190 days after receiving the submission on October 28, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K023615 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 28, 2002 |
| Decision Date | May 06, 2003 |
| Days to Decision | 190 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 |