FDA 510(k) Application Details - K181865

Device Classification Name	Accessories, Cleaning, For Endoscope   More FDA Info for this Device
510(K) Number	K181865
Device Name	Accessories, Cleaning, For Endoscope
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Gregory Land 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	07/12/2018
Decision Date	12/14/2018
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