FDA 510(k) Application Details - K071912

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K071912
Device Name	Filler, Bone Void, Calcium Compound
Applicant	PENTAX CORP. 5600 WISCONSIN AVENUE SUITE 509 CHEVY CHASE, MD 20815 US Other 510(k) Applications for this Company
Contact	PATSY J TRISLER 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	07/11/2007
Decision Date	10/29/2007
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