FDA 510(k) Application Details - K180553

Device Classification Name	More FDA Info for this Device
510(K) Number	K180553
Device Name	VERIFY Spore Test Strip for S40 Sterilant
Applicant	Steris Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Marcia L. Benedict Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2018
Decision Date	05/29/2018
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