FDA 510(k) Application Details - K010701

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K010701
Device Name	Bone Grafting Material, Synthetic
Applicant	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	RIHCARD W TREHARNE 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	03/08/2001
Decision Date	06/05/2001
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