510(k) K964690
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1997
- Date Received
- November 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type