Enbio S

Sterilizer, Steam

Enbio Group AG

The following data is part of a premarket notification filed by Enbio Group Ag with the FDA for Enbio S.

Pre-market Notification Details

Device IDK210279
510k NumberK210279
Device Name:Enbio S
ClassificationSterilizer, Steam
Applicant Enbio Group AG Eichengasse 3 Oensingen,  CH Ch-4702
ContactLukasz Rogowski
CorrespondentLukasz Rogowski
Enbio Group AG Eichengasse 3 Oensingen,  CH Ch-4702
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-10-29

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