FDA 510(k) Application Details - K052833

Device Classification Name Drape, Surgical

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510(K) Number K052833
Device Name Drape, Surgical
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact JENNIFER MASON
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 10/06/2005
Decision Date 02/15/2006
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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