FDA 510(k) Application Details - K233026

Device Classification Name Sterilizer, Steam

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510(K) Number K233026
Device Name Sterilizer, Steam
Applicant Midmark Corporation
60 Vista Drive
Versailles, OH 45380 US
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Contact Adam Clutter
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 09/22/2023
Decision Date 04/04/2024
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

FDA Source Information for K233026


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