FDA 510(k) Application Details - K101827

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K101827
Device Name	Bone Grafting Material, Synthetic
Applicant	TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL 4808 RESEARCH DRIVE SAN ANTONIO, TX 78240 US Other 510(k) Applications for this Company
Contact	JERRY CHANG 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	07/01/2010
Decision Date	04/20/2011
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