FDA 510(k) Application Details - K083372

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K083372
Device Name	Bone Grafting Material, Synthetic
Applicant	BRAINBASE CORPORATION 26420 SUMMER GREENS DR. BONITA SPRINGS, FL 34135 US Other 510(k) Applications for this Company
Contact	H. NEAL DUNNING Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2008
Decision Date	12/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review