FDA 510(k) Application Details - K103799

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K103799
Device Name	Filler, Bone Void, Calcium Compound
Applicant	ISTO TECHNOLOGIES, INC. 5600 WISCONSIN AVE. #509 CHEVY CHASE, MD 20815 US Other 510(k) Applications for this Company
Contact	PATSY J TRISLER, JD, RAC 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	12/28/2010
Decision Date	08/29/2011
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