510(k) K914908
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 13, 1992
- Date Received
- November 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type