K812615 is an FDA 510(k) clearance for the TM-CAPD. This device is classified as a Peritoneal Dialysate Filter (Class II - Special Controls, product code KPP).
Submitted by Tri-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982, 112 days after receiving the submission on September 15, 1981.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K812615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1981 |
| Decision Date | January 05, 1982 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KPP — Peritoneal Dialysate Filter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |