K974090 is an FDA 510(k) clearance for the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS. This device is classified as a Hemodialyzer, Re-use, Low Flux (Class II - Special Controls, product code MSE).
Submitted by Fresenius Medical Care North America (Walnut Creek, US). The FDA issued a Cleared decision on August 27, 1998, 302 days after receiving the submission on October 29, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K974090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1997 |
| Decision Date | August 27, 1998 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSE — Hemodialyzer, Re-use, Low Flux |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |