510(k) K090695
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2009
- Date Received
- March 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device Class
- Class II
- Regulation Number
- 882.4460
- Review Panel
- NE
- Submission Type