FDA 510(k) Application Details - K042164

Device Classification Name Dressing, Wound, Drug

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510(K) Number K042164
Device Name Dressing, Wound, Drug
Applicant MEDLINE INDUSTRIES, INC.
12232 SW GARDEN PL.
PORTLAND, OR US
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Contact BRUCE GIBBINS
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 08/11/2004
Decision Date 06/09/2005
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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