510(k) K100744
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2010
- Date Received
- March 16, 2010
- 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