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FDA 510(k) Application Details - K143017
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K143017
Device Name
Dressing, Wound, Drug
Applicant
LABORATOIRES URGO
42 RUE DE LONGVIC
CHENOVE 21300 FR
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Contact
SOPHIE FORTIN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2014
Decision Date
08/07/2015
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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