K083785 is an FDA 510(k) clearance for the VITALA CONTINENCE CONTROL DEVICE. This device is classified as a Pouch, Colostomy (Class I - General Controls, product code EZQ).
Submitted by Convatec (Skillman, US). The FDA issued a Cleared decision on April 2, 2010, 469 days after receiving the submission on December 19, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K083785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2008 |
| Decision Date | April 02, 2010 |
| Days to Decision | 469 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZQ - Pouch, Colostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |