FDA 510(k) Application Details - K041833

Device Classification Name Sterilizer, Steam

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510(K) Number K041833
Device Name Sterilizer, Steam
Applicant CONSOLIDATED MACHINE CORP.
76 ASHFORD ST.
BOSTON, MA 02134 US
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Contact ARTHUR TRAPOTSIS
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 07/07/2004
Decision Date 12/10/2004
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 N
Expedited Review



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