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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 K021223
Device Name BELIMED STEAM STERILIZER, MODEL TOP 5000
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 MARK JOB
Regulation Number880.6880
Classification Product Code
FLE  
Date Received04/18/2002
Decision Date 06/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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