FDA 510(k) Application Details - K091325

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K091325
Device Name	Densitometer, Bone
Applicant	COOPER SURGICAL 95 CORPORATE DR. TRUMBULL, CT 06611 US Other 510(k) Applications for this Company
Contact	THOMAS G WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	892.1170   More FDA Info for this Regulation Number
Classification Product Code	KGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2009
Decision Date	06/29/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review