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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 K192463
Device Name PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua District
Shenzhen,  CN 518109
Applicant Contact Dan Wang
Correspondent
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua District
Shenzhen,  CN 518109
Correspondent Contact Dan Wang
Classification Product Code
FRO  
Date Received09/09/2019
Decision Date 05/14/2020
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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