K781736 is an FDA 510(k) clearance for the DISC, COLOPLAST PRE-OP STOMA. This device is classified as a Selector, Size, Ostomy (Class I - General Controls, product code EXA).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978, 22 days after receiving the submission on October 12, 1978.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K781736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1978 |
| Decision Date | November 03, 1978 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXA — Selector, Size, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |