FDA 510(k) Application Details - K103602

Device Classification Name Latex Patient Examination Glove

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510(K) Number K103602
Device Name Latex Patient Examination Glove
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060-4486 US
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Contact MATT CLAUSEN
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/08/2010
Decision Date 04/21/2011
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 N
Expedited Review



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