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FDA 510(k) Application Details - DEN110006
Device Classification Name
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510(K) Number
DEN110006
Device Name
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
ROBERT SULLIVAN
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Regulation Number
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Classification Product Code
OWP
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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
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