510(k) K854173
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1985
- Date Received
- October 15, 1985
- 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