FDA 510(k) Application Details - K083913

Device Classification Name Bandage, Liquid

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510(K) Number K083913
Device Name Bandage, Liquid
Applicant CHESSON LABORATORY ASSOCIATES, INC.
3100 TOWER BLVD., SUITE 117
DURHAM, NC 27707 US
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Contact SCOTT E NEUVILLE
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 12/30/2008
Decision Date 07/31/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
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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