FDA 510(k) Application Details - K080308

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K080308
Device Name	Bone Grafting Material, Synthetic
Applicant	BIOSCAFFOLD INTERNATIONAL PTE LTD PIAZZA ALBANIA, 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	ROGER GRAY 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	02/05/2008
Decision Date	04/14/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review