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FDA 510(k) Application Details - K203061
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K203061
Device Name
Sterilizer, Steam
Applicant
STERIS Corporation
5960 Heisley Rd
Mentor, OH 44060 US
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Contact
Anthony Piotrkowski
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Regulation Number
880.6880
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
10/08/2020
Decision Date
11/06/2020
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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