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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 K152926
Device Name AQUACEL Ag Surgical SP Dressing
Applicant
CONVATEC LIMITED
FIRST AVENUE, DEESIDE INDUSTRIAL PARK
DEESIDE,  GB CH5 2NU
Applicant Contact AARON SIBLEY
Correspondent
CONVATEC LIMITED
FIRST AVENUE, DEESIDE INDUSTRIAL PARK
DEESIDE,  GB CH5 2NU
Correspondent Contact AARON SIBLEY
Classification Product Code
FRO  
Date Received10/05/2015
Decision Date 01/21/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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