FDA 510(k) Application Details - K121177

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K121177
Device Name	Bone Grafting Material, Synthetic
Applicant	AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A THOMAS 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	04/18/2012
Decision Date	12/05/2013
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