510(k) K011736
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2002
- Date Received
- June 5, 2001
- 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