510(k) K051052
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2005
- Date Received
- April 25, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryosurgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4350
- Review Panel
- SU
- Submission Type