FDA 510(k) Application Details - K111223

Device Classification Name Sterilizer, Steam

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510(K) Number K111223
Device Name Sterilizer, Steam
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact ROBERT F SULLIVAN
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 05/02/2011
Decision Date 09/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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