FDA 510(k) Application Details - K103331

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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510(K) Number K103331
Device Name Indicator, Physical/Chemical Sterilization Process
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact ROBERT F SULLIVAN
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Regulation Number 880.2800

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Classification Product Code JOJ
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Date Received 11/12/2010
Decision Date 09/01/2011
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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