FDA 510(k) Application Details - K162120

Device Classification Name	Accessories, Cleaning, For Endoscope   More FDA Info for this Device
510(K) Number	K162120
Device Name	Accessories, Cleaning, For Endoscope
Applicant	Custom Ultrasonics Inc. 144 Railroad Drive Ivyland, PA 18974 US Other 510(k) Applications for this Company
Contact	Elizabeth Lazaro Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2016
Decision Date	04/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review