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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 K123219
Device Name URGOCLEAN ABSORBENT WOUND DRESSING
Applicant
Laboratoires Urgo
Excellence 2000
2 Ave. De Strasbourg
Chevigny Saint Sauveur,  FR 21801
Applicant Contact SOPHIE FORTIN
Correspondent
Laboratoires Urgo
Excellence 2000
2 Ave. De Strasbourg
Chevigny Saint Sauveur,  FR 21801
Correspondent Contact SOPHIE FORTIN
Classification Product Code
FRO  
Date Received10/15/2012
Decision Date 03/18/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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