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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K143017
Device Name Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
Applicant
Laboratoires Urgo
42 Rue De Longvic
21300 Chenove,  FR 21300
Applicant Contact SOPHIE FORTIN
Correspondent
Laboratoires Urgo
42 Rue De Longvic
21300 Chenove,  FR 21300
Correspondent Contact SOPHIE FORTIN
Classification Product Code
FRO  
Date Received10/20/2014
Decision Date 08/07/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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