URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

Dressing, Wound, Drug

LABORATOIRES URGO

The following data is part of a premarket notification filed by Laboratoires Urgo with the FDA for Urgocell Ag, Antimicrobial Wound Dressing With Silver.

Pre-market Notification Details

Device IDK100429
510k NumberK100429
Device Name:URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
ClassificationDressing, Wound, Drug
Applicant LABORATOIRES URGO 42, RUE DE LONGVIC Chenove,  FR 21300
ContactSophie Fortin
CorrespondentSophie Fortin
LABORATOIRES URGO 42, RUE DE LONGVIC Chenove,  FR 21300
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2010-02-16
Decision Date2010-06-11
Summary:summary

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