FDA 510(k) Application Details - K082576

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K082576
Device Name	Choledochoscope And Accessories, Flexible/Rigid
Applicant	OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 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	FBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2008
Decision Date	10/21/2008
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