FDA 510(k) Application Details - K093726

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K093726
Device Name Polymer Patient Examination Glove
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact MATT CLAUSEN
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 12/03/2009
Decision Date 02/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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