510(k) K935163
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1994
- Date Received
- October 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystourethroscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type