510(k) K091382
Clearance Details
- Decision
- SESU ()
- Decision Date
- November 16, 2009
- Date Received
- May 11, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methyl Methacrylate For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5300
- Review Panel
- NE
- Submission Type