510(k) K111365
K111365 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "VITALA CONTINENCE CONTROL DEVICE". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code EZQ (Pouch, Colostomy), a Class I device regulated under 21 CFR 876.5900. Convatec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2011
- Date Received
- May 16, 2011
- 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