510(k) K041610
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2004
- Date Received
- June 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resectoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type