FDA 510(k) Application Details - K232914

Device Classification Name Sterilant, Medical Devices

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510(K) Number K232914
Device Name Sterilant, Medical Devices
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact Jennifer Nalepka
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 09/19/2023
Decision Date 10/03/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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