FDA 510(k) Application Details - K153230

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K153230
Device Name	Bone Grafting Material, Synthetic
Applicant	THE IMPLANTECH INC./SHEFABONE 9016 CLIFF CAMERON DR., #201 CHARLOTTE, NC 28269 US Other 510(k) Applications for this Company
Contact	AHMED EL-GHANNAM 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	11/06/2015
Decision Date	07/14/2016
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