FDA 510(k) Application Details - K123219

Device Classification Name Dressing, Wound, Drug

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510(K) Number K123219
Device Name Dressing, Wound, Drug
Applicant LABORATOIRES URGO
EXCELLENCE 2000
2 AVENUE DE STRASBOURG
CHEVIGNY SAINT SAUVEUR 21801 FR
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Contact SOPHIE FORTIN
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/15/2012
Decision Date 03/18/2013
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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