510(k) K951474
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1995
- Date Received
- March 30, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type