K042797 is an FDA 510(k) clearance for the WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. 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 March 9, 2005, 152 days after receiving the submission on October 8, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K042797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2004 |
| Decision Date | March 09, 2005 |
| Days to Decision | 152 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIP — Subsystem, Water Purification |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5665 |