FDA 510(k) Application Details - K083155

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K083155
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	STACY A KLUESNER 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	10/24/2008
Decision Date	01/13/2009
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