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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 K191896
Device Name Belimed Steam Sterilizer MST-H TOP 5000
Applicant
Belimed AG
Grienbachstrasse 11
Zug,  CH 6300
Applicant Contact Marc Luthi
Correspondent
Belimed AG
Grienbachstrasse 11
Zug,  CH 6300
Correspondent Contact Marc Luthi
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/15/2019
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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