AMSCO 600 Medium Steam Sterilizer

Sterilizer, Steam

Steris Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco 600 Medium Steam Sterilizer.

Pre-market Notification Details

Device IDK211500
510k NumberK211500
Device Name:AMSCO 600 Medium Steam Sterilizer
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-14
Decision Date2021-08-25

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