FDA 510(k) Application Details - K060623

Device Classification Name	Anoscope And Accessories   More FDA Info for this Device
510(K) Number	K060623
Device Name	Anoscope And Accessories
Applicant	COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK LIMERICK IE Other 510(k) Applications for this Company
Contact	EMMETT DEVEREUX Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2006
Decision Date	09/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review