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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K252001
Device Name Collagen Wound Dressing
Applicant
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua Dist.
42nd Floor Bldg. No 2, Huilong Business Center, Longhua
Shenzhen,  CN 518109
Applicant Contact Ziling Shangguan
Correspondent
Winner Medical Co., Ltd.
Winner Industrial Park, #660 Bulong Rd., Longhua Dist.
42nd Floor Bldg. No 2, Huilong Business Center, Longhua
Shenzhen,  CN 518109
Correspondent Contact Ziling Shangguan
Classification Product Code
KGN  
Date Received06/27/2025
Decision Date 10/10/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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