FDA 510(k) Application Details - K103841

Device Classification Name Sterilizer, Steam

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510(K) Number K103841
Device Name Sterilizer, Steam
Applicant SAUTER AG
ZELGSTRASSE 8
SULGEN TG CH-8583 CH
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Contact HANS STADLER
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 12/22/2010
Decision Date 03/15/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review

FDA Source Information for K103841


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