510(k) K043155
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2004
- Date Received
- November 15, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cautery, Thermal, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4115
- Review Panel
- OP
- Submission Type