FDA 510(k) Application Details - K102177

Device Classification Name Surgeon'S Gloves

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510(K) Number K102177
Device Name Surgeon'S Gloves
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact MATT CLAUSEN
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 08/02/2010
Decision Date 06/30/2011
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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