FDA 510(k) Application Details - K163492

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K163492
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	United states Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Carroll Martin Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2016
Decision Date	01/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review