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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 K033538
Device Name BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
Applicant
Sauter AG
Zelgstrasse 8
Sulgen (Tg),  CH CH-8583
Applicant Contact HANS STADLER
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/10/2003
Decision Date 02/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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