FDA 510(k) Application Details - K061220

Device Classification Name Dressing, Wound, Drug

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510(K) Number K061220
Device Name Dressing, Wound, Drug
Applicant LABORATOIRES URGO
42, RUE DE LONGVIC
CHENOVE 21300 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 05/01/2006
Decision Date 07/27/2006
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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