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FDA 510(k), K071937, BONALIVE GRANULES AND BONALIVE PLATES
FDA 510(k), K071937, BONALIVE GRANULES AND BONALIVE PLATES
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510(K) Number: K071937
Device Name: BONALIVE GRANULES AND BONALIVE PLATES
Manufacturer: CONSTANCE G BUNDY
Device Classification Name: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation Number: KKY
Classification Product Code: 07/13/2007
Date Received: 10/19/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BONALIVE GRANULES AND BONALIVE PLATES
Manufacturer: CONSTANCE G BUNDY
Device Classification Name: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation Number: KKY
Classification Product Code: 07/13/2007
Date Received: 10/19/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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