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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name liquid chemical processing system
De Novo Number DEN110002
510(K) Number K100049
Device Name SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT
Requester
steris corporation
5960 heisley road
mentor,  OH  44060
Contact robert sullivan
Regulation Number880.6887
Classification Product Code
OVY  
Date Received08/01/2011
Decision Date 03/30/2012
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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