FDA 510(k) Application Details - K103141

Device Classification Name Dressing, Wound, Drug

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510(K) Number K103141
Device Name Dressing, Wound, Drug
Applicant MILLIKEN HEALTHCARE PRODUCTS, LLC
11440 W. BERNARDO COURT
SUITE 300
SAN DIEGO, CA 92127 US
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Contact RONALD S WARREN, RAC
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/25/2010
Decision Date 01/21/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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