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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 K163062
Device Name PHMB Antimicrobial Foam Wound Dressing
Applicant
Advanced Medical Solutions, Ltd.
Premier Park, 33 Rd. One
Winsford Industrial Estate
Winsford,  GB CW7 3RT
Applicant Contact Kay McGrath
Correspondent
Advanced Medical Solutions, Ltd.
Premier Park, 33 Rd. One
Winsford Industrial Estate
Winsford,  GB CW7 3RT
Correspondent Contact Kay McGrath
Classification Product Code
FRO  
Date Received11/02/2016
Decision Date 07/25/2017
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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