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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K213991
Device Name Enbio S
Applicant
Enbio Group AG
Eichengasse 3
Oensingen,  CH CH-4702
Applicant Contact Lukasz Rogowski
Correspondent
Enbio Group AG
Eichengasse 3
Oensingen,  CH CH-4702
Correspondent Contact Lukasz Rogowski
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/21/2021
Decision Date 02/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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