510(k) K925960
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1994
- Date Received
- November 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator, Culdoscopic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4160
- Review Panel
- OB
- Submission Type