AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers

Sterilizer, Steam

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco 400 Small Steam Sterilizers, Amsco 400 Medium Steam Sterilizers.

Pre-market Notification Details

Device IDK212424
510k NumberK212424
Device Name:AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
ClassificationSterilizer, Steam
Applicant STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
ContactAnthony Piotrkowski
CorrespondentAnthony Piotrkowski
STERIS Corporation 5960 Heisley Rd Mentor,  OH  44060
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2021-10-28

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