FDA 510(k) Application Details - K111243

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K111243
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	FUJINON INC. 419 WEST AVENUE STAMFORD, CT 06902 US Other 510(k) Applications for this Company
Contact	KATHERINE Y CHOI 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	05/03/2011
Decision Date	05/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review