FDA 510(k) Application Details - K162701

Device Classification Name	More FDA Info for this Device
510(K) Number	K162701
Device Name	VERIFY Assert Self-Contained Biological Indicator
Applicant	STERIS CORPORATION 5960 HEISLEY RD MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	ANTHONY PIOTRKOWSKI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2016
Decision Date	03/24/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review