510(k) K945493
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1995
- Date Received
- November 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cautery, Thermal, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4115
- Review Panel
- OP
- Submission Type