FDA 510(k) Application Details - K191715

Device Classification Name	Endoscopic Storage Cover   More FDA Info for this Device
510(K) Number	K191715
Device Name	Endoscopic Storage Cover
Applicant	STERIS Corporation 5976 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	OCU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2019
Decision Date	01/27/2020
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