FDA 510(k) Application Details - K112769

Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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510(K) Number K112769
Device Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Applicant MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact MATT CLAUSEN
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Regulation Number 880.5780

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Classification Product Code DWL
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Date Received 09/23/2011
Decision Date 03/01/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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