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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 K213473
Device Name Antimicrobial Gelling Fiber Dressing with PHMB
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 Received10/28/2021
Decision Date 10/26/2023
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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