510(k) K901795
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 8, 1990
- Date Received
- April 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Gastro-Enterostomy
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type