510(k) K032601
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2004
- Date Received
- August 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Lesion, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 882.4400
- Review Panel
- NE
- Submission Type