FDA 510(k) Application Details - K200577

Device Classification Name	Washer, Cleaner, Automated, Endoscope   More FDA Info for this Device
510(K) Number	K200577
Device Name	Washer, Cleaner, Automated, Endoscope
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Jennifer Nalepka Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2020
Decision Date	04/03/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review