FDA 510(k) Application Details - DEN110002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN110002
Device Name	SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
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	OVY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2011
Decision Date	03/30/2012
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