510(k) K024359
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2003
- Date Received
- December 30, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5300
- Review Panel
- NE
- Submission Type