FDA 510(k) Application Details - K051541

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K051541
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2005
Decision Date	07/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review