FDA 510(k) Application Details - DEN110006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN110006
Device Name	VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	ROBERT SULLIVAN 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	09/06/2011
Decision Date	07/12/2013
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review