510(k) K090272
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2009
- Date Received
- February 4, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Self-Retaining, For Neurosurgery
- Device Class
- Class II
- Regulation Number
- 882.4800
- Review Panel
- NE
- Submission Type