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FDA 510(k) Application Details - K230582
Device Classification Name
Sterilant, Medical Devices
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510(K) Number
K230582
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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More FDA Info for this Product Code
Date Received
03/02/2023
Decision Date
03/28/2023
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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