The following data is part of a premarket notification filed by Convatec with the FDA for Vitala Continence Control Device.
| Device ID | K083785 |
| 510k Number | K083785 |
| Device Name: | VITALA CONTINENCE CONTROL DEVICE |
| Classification | Pouch, Colostomy |
| Applicant | CONVATEC 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Marilyn Konicky |
| Correspondent | Marilyn Konicky CONVATEC 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | EZQ |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-19 |
| Decision Date | 2010-04-02 |
| Summary: | summary |