Getinge GSS610N Series Steam Sterilizer

Sterilizer, Steam

Maquet GmbH

The following data is part of a premarket notification filed by Maquet Gmbh with the FDA for Getinge Gss610n Series Steam Sterilizer.

Pre-market Notification Details

Device IDK201927
510k NumberK201927
Device Name:Getinge GSS610N Series Steam Sterilizer
ClassificationSterilizer, Steam
Applicant Maquet GmbH Kehler Strasse 31 Rastatt,  DE 76437
ContactHolger Ullrich
CorrespondentMark Smith
Getinge 45 Barbour Pond Road Wayne,  NY  07470
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2021-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04053275000080 K201927 000
04053275000073 K201927 000
04053275000066 K201927 000

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