FDA 510(k) Application Details - K100622

Device Classification Name Sterilizer, Steam

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510(K) Number K100622
Device Name Sterilizer, Steam
Applicant BELIMED 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 03/04/2010
Decision Date 08/27/2010
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 K100622


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