FDA 510(k) Application Details - K152923

Device Classification Name Dressing, Wound, Drug

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510(K) Number K152923
Device Name Dressing, Wound, Drug
Applicant AVERY DENNISON BELGIE BVBA
TIEBLOKKENLAAN 1
TURNHOUT B-2300 BE
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Contact LISA BARTAKOVICS
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/05/2015
Decision Date 11/05/2015
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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