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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 K181315
Device Name Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua District
Shenzhen,  CN 518109
Applicant Contact Dan Wang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Classification Product Code
FRO  
Date Received05/18/2018
Decision Date 02/14/2019
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
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