510(k) K083157
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2009
- Date Received
- October 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type