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FDA 510(k) Application Details - K210279
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K210279
Device Name
Sterilizer, Steam
Applicant
Enbio Group AG
Eichengasse 3
Oensingen CH-4702 CH
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Contact
Lukasz Rogowski
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
02/01/2021
Decision Date
10/29/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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