510(k) K083785
K083785 is an FDA 510(k) premarket notification submitted by Convatec for the device "VITALA CONTINENCE CONTROL DEVICE". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code EZQ (Pouch, Colostomy), a Class I device regulated under 21 CFR 876.5900. Convatec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2010
- Date Received
- December 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pouch, Colostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type