K883239 is an FDA 510(k) clearance for the CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on October 21, 1988, 81 days after receiving the submission on August 1, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K883239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1988 |
| Decision Date | October 21, 1988 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |