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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 K183645
Device Name Silver High Performance Dressing
Applicant
Advanced Medical Solutions, Ltd.
Premier Park, 33, Winsford Industrial Estate
Winsford,  GB CW7 3RT
Applicant Contact Amy Turner
Correspondent
Advanced Medical Solutions, Ltd.
Premier Park, 33, Winsford Industrial Estate
Winsford,  GB CW7 3RT
Correspondent Contact Amy Turner
Classification Product Code
FRO  
Date Received12/26/2018
Decision Date 05/29/2019
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
Recalls CDRH Recalls
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