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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 K252167
Device Name Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
Applicant
Qingdao Bright Moon Biomedical Materials Co., Ltd.
# 788, Bright Moon Rd., Huangdao District
Qingdao,  CN 266499
Applicant Contact Yunlong Deng
Correspondent
Qingdao Bright Moon Biomedical Materials Co., Ltd.
# 788, Bright Moon Rd., Huangdao District
Qingdao,  CN 266499
Correspondent Contact Huixin Wang
Classification Product Code
FRO  
Date Received07/10/2025
Decision Date 12/19/2025
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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