FDA 510(k) Application Details - K083659

Device Classification Name Dressing, Wound, Drug

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510(K) Number K083659
Device Name Dressing, Wound, Drug
Applicant MILLIKEN & CO.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 12/10/2008
Decision Date 04/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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