FDA 510(k) Application Details - K133538

Device Classification Name	Endoscope, Accessories, Narrow Band Spectrum   More FDA Info for this Device
510(K) Number	K133538
Device Name	Endoscope, Accessories, Narrow Band Spectrum
Applicant	OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY P.O. BOX 610 CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2013
Decision Date	08/07/2014
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