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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 K221754
Device Name Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road,
Loughua District
Shenzhen,  CN 518109
Applicant Contact Zhiqin Liang
Correspondent
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road,
Loughua District
Shenzhen,  CN 518109
Correspondent Contact Mingni Liu
Classification Product Code
FRO  
Date Received06/16/2022
Decision Date 01/17/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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