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FDA 510(k) Application Details - K062297
Device Classification Name
Sterilizer, Chemical
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510(K) Number
K062297
Device Name
Sterilizer, Chemical
Applicant
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact
PATRICK J MCCULLAGH
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Regulation Number
880.6860
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Classification Product Code
MLR
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More FDA Info for this Product Code
Date Received
08/07/2006
Decision Date
10/04/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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