510(k) K863830
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1986
- Date Received
- September 30, 1986
- 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