FDA 510(k) Application Details - K093616

Device Classification Name	Endoscope Holder   More FDA Info for this Device
510(K) Number	K093616
Device Name	Endoscope Holder
Applicant	CAREFUSION 2200 1500 WAUKEGAN ROAD WAUKEGAN, IL 60085 US Other 510(k) Applications for this Company
Contact	GINA RAJTEROWSKI Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2009
Decision Date	12/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review