K970700 is an FDA 510(k) clearance for the FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX, a Hemodialyzer, Re-use, Low Flux (Class II — Special Controls, product code MSE), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on September 15, 1998, 567 days after receiving the submission on February 25, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K970700 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 1997 |
| Decision Date | September 15, 1998 |
| Days to Decision | 567 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MSE — Hemodialyzer, Re-use, Low Flux |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |