FDA 510(k) Application Details - K113873

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K113873
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	PENTAX OF AMERICA, INC. 1129 BLOOMFIELD AVENUE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2011
Decision Date	06/22/2012
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