The following data is part of a premarket notification filed by Convatec Inc with the FDA for Vitala Continence Control Device.
| Device ID | K102536 |
| 510k Number | K102536 |
| Device Name: | VITALA CONTINENCE CONTROL DEVICE |
| Classification | Pouch, Colostomy |
| Applicant | CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman, NJ 08558 |
| Contact | Charles Ryan |
| Correspondent | Charles Ryan CONVATEC INC 200 HEADQUARTERS PARK DRIVE 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 | 2010-09-03 |
| Decision Date | 2010-12-01 |
| Summary: | summary |