K780409 is an FDA 510(k) clearance for the COLOPLAST-DURASEAL OSTOMY APPLIANCE. This device is classified as a Appliance, Colostomy, Disposable (Class I - General Controls, product code EZS).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on April 27, 1978, 45 days after receiving the submission on March 13, 1978.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K780409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1978 |
| Decision Date | April 27, 1978 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EZS — Appliance, Colostomy, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |