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FDA 510(k) Application Details - K163587
Device Classification Name
More FDA Info for this Device
510(K) Number
K163587
Device Name
VERIFY Incubator for Assert Self Contained Biological Indicators
Applicant
STERIS Corporation
5976 Heisley Rd
Mentor, OH 44060 US
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Contact
Anthony Piotrkowski
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Regulation Number
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Classification Product Code
OWP
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Date Received
12/20/2016
Decision Date
03/24/2017
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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