510(k) K911788
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1991
- Date Received
- April 22, 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