FDA 510(k) Application Details - K090950

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K090950
Device Name	Bone Grafting Material, Synthetic
Applicant	MEGAGEN IMPLANT CO., LTD 13340 E. FIRESTONE BLVD. SUITE J SANTA FE SPRINGS, CA 90670 US Other 510(k) Applications for this Company
Contact	JOYCE BANG 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	04/03/2009
Decision Date	07/02/2010
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