FDA 510(k) Application Details - K120446

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K120446
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	FUJINON, INC. 10 HIGH POINT DR. WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	MARK JOB Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2012
Decision Date	08/13/2012
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