510(k) K053415
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2006
- Date Received
- December 7, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type