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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
Recalls CDRH Recalls
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