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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 K252028
Device Name LUOFUCON® Antimicrobial Wound Gel
Applicant
Huizhou Foryou Medical Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Applicant Contact Huiqi Huang
Correspondent
Huizhou Foryou Medical Co., Ltd.
North Shangxia Rd. Dongjiang Hi-Tech Industry Park
Huizhou,  CN 516005
Correspondent Contact Huiqi Huang
Classification Product Code
FRO  
Date Received06/30/2025
Decision Date 03/11/2026
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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