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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 K090339
Device Name BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
Applicant
Belimed Sauter AG
2284 Clements Ferry Rd.
Charleston,  SC  29412
Applicant Contact CHRIS P MANNARINO
Correspondent
Belimed Sauter AG
2284 Clements Ferry Rd.
Charleston,  SC  29412
Correspondent Contact CHRIS P MANNARINO
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/10/2009
Decision Date 09/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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