510(k) K050933
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2005
- Date Received
- April 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4100
- Review Panel
- OP
- Submission Type