K003957 is an FDA 510(k) clearance for the DIACLEAR ULTRAFILTER. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on November 1, 2001, 315 days after receiving the submission on December 21, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K003957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2000 |
| Decision Date | November 01, 2001 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIP — Subsystem, Water Purification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |