510(k) K071937
K071937 is an FDA 510(k) premarket notification submitted by Vivoxid , Ltd. for the device "BONALIVE GRANULES AND BONALIVE PLATES". The FDA issued a decision of Substantially Equivalent on October 19, 2007. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Vivoxid , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2007
- Date Received
- July 13, 2007
- 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