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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 K100622
Device Name BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
Applicant
Belimed Sauter AG
Zelgstrasse 8
Sulgen (Tg),  CH CH-8583
Applicant Contact HANS STADLER
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/04/2010
Decision Date 08/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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