510(k) K921071
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1992
- Date Received
- March 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Suprapubic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type