510(k) K131133
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2013
- Date Received
- April 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type