K091360 is an FDA 510(k) clearance for the CLEARFLUX DIALYZER REPROCESSING SYSTEM. This device is classified as a Dialyzer Reprocessing System (Class II - Special Controls, product code LIF).
Submitted by Novaflux Technologies (Princeton, US). The FDA issued a Cleared decision on November 3, 2010, 544 days after receiving the submission on May 8, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K091360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2009 |
| Decision Date | November 03, 2010 |
| Days to Decision | 544 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LIF — Dialyzer Reprocessing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |