510(k) K062406
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2006
- Date Received
- August 17, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Paddie
- Device Class
- Class II
- Regulation Number
- 882.4700
- Review Panel
- NE
- Submission Type