FDA 510(k) Application Details - K091022

Device Classification Name Sterilant, Medical Devices

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510(K) Number K091022
Device Name Sterilant, Medical Devices
Applicant STERIS Corporation
REGULATORY AFFAIRS/CORPORATE
5960 HEISLEY RD.
MENTOR, OH 44060 US
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Contact JOHN SCOVILLE JR.
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 04/09/2009
Decision Date 04/12/2010
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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