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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 K173675
Device Name AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
Applicant
Convatec Limited
First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact Justin Lovelace
Correspondent
Convatec Limited
First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact Justin Lovelace
Classification Product Code
FRO  
Date Received11/30/2017
Decision Date 07/20/2018
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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