FDA 510(k) Application Details - K014174

Device Classification Name Sterilizer, Steam

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510(K) Number K014174
Device Name Sterilizer, Steam
Applicant BARNSTEAD/THERMOLYNE CORP.
P.O. BOX 797
DUBUQUE, IA 52001 US
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Contact MIA M WARE
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 12/20/2001
Decision Date 02/22/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review

FDA Source Information for K014174


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