FDA 510(k) Application Details - K083005

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K083005
Device Name	Bone Grafting Material, Synthetic
Applicant	TEKNIMED SA 1001 OAKWOOD BLVD ROUNDROCK, TX 78681 US Other 510(k) Applications for this Company
Contact	J.D. WEBB 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	10/08/2008
Decision Date	03/04/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review