510(k) K925116
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1994
- Date Received
- October 9, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, And Accessories, Dental
- Device Class
- Class II
- Regulation Number
- 872.4920
- Review Panel
- DE
- Submission Type