K840269 is an FDA 510(k) clearance for the MC 2000 OSTOMY POUCHES. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by Coloplast A/S (Walker, US). The FDA issued a Cleared decision on April 2, 1984, 70 days after receiving the submission on January 23, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K840269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1984 |
| Decision Date | April 02, 1984 |
| Days to Decision | 70 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 |