FDA 510(k) Application Details - K151345

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K151345
Device Name	Endoscope Channel Accessory
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	CARROLL L. MARTIN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2015
Decision Date	08/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review