FDA 510(k) Application Details - K063023

Device Classification Name Respirator,Surgical

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510(K) Number K063023
Device Name Respirator,Surgical
Applicant 3M COMPANY
3M CENTER BUILDING 275-05W-06
ST. PAUL, MN 55144 US
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Contact DIANNE GIBBS
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Regulation Number 878.4040

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Classification Product Code MSH
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Date Received 10/02/2006
Decision Date 02/23/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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