FDA 510(k) Application Details - K113836

Device Classification Name Dressing, Wound, Drug

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510(K) Number K113836
Device Name Dressing, Wound, Drug
Applicant AVERY DENNISON BELGIE, BVBA
20N. WACKER DRIVE
SUITE 2240
CHICAGO, IL 60606 US
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Contact JERZY WOJCIK
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 12/28/2011
Decision Date 09/24/2012
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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