FDA 510(k) Application Details - K163587

Device Classification Name	More FDA Info for this Device
510(K) Number	K163587
Device Name	VERIFY Incubator for Assert Self Contained Biological Indicators
Applicant	STERIS Corporation 5976 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	12/20/2016
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