K921134 is an FDA 510(k) clearance for the FRESENIUS POLYSULFONE DIALYZERS, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on December 2, 1993, 632 days after receiving the submission on March 10, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K921134 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 1992 |
| Decision Date | December 02, 1993 |
| Days to Decision | 632 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |