FDA 510(k) Application Details - K973704

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K973704
Device Name	Filler, Bone Void, Calcium Compound
Applicant	BIOGENERATION 9160 HIGHWAY 64 SUITE 12 ARLINGTON, TN 38002 US Other 510(k) Applications for this Company
Contact	BERNARD F GRISONI Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/1997
Decision Date	04/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review