FDA 510(k) Application Details - K162428

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K162428
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	Lumendi, LLC 253 Post Road West Westport, CT 06880 US Other 510(k) Applications for this Company
Contact	Dennis Daniels 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	08/30/2016
Decision Date	12/06/2016
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