K771775 is an FDA 510(k) clearance for the COLORPLAST TRANSVERSE SYSTEM. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1977, 11 days after receiving the submission on September 19, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K771775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1977 |
| Decision Date | September 30, 1977 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |