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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 K141879
Device Name BELIMED STEAM STERILIZER MST-H
Applicant
Sauter AG
Zelgstrasse 8
Sulgen (Tg),  CH CH-8583
Applicant Contact MICHAEL HARI
Correspondent
Sauter AG
Zelgstrasse 8
Sulgen (Tg),  CH CH-8583
Correspondent Contact MICHAEL HARI
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/11/2014
Decision Date 06/17/2015
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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