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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 biological sterilization process indicator with recombinant-dna plasmid
De Novo Number DEN110006
510(K) Number K102469
Device Name VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Requester
steris corporation
5960 heisley rd.
mentor,  OH  44060
Contact robert sullivan
Regulation Number880.2805
Classification Product Code
OWP  
Date Received09/06/2011
Decision Date 07/12/2013
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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