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FDA 510(k) Application Details - K173634
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K173634
Device Name
Indicator, Biological Sterilization Process
Applicant
STERIS Corporation
5976 Heisley Rd
Mentor, OH 44060 US
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Contact
Anthony Piotrkowski
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Regulation Number
880.2800
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Classification Product Code
FRC
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More FDA Info for this Product Code
Date Received
11/24/2017
Decision Date
02/12/2018
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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