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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 K221110
Device Name LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd., Dongjiang Hi-Tech Industrial Park
Huizhou,  CN 516005
Applicant Contact Jie Dong
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd., Dongjiang Hi-Tech Industrial Park
Huizhou,  CN 516005
Correspondent Contact Jie Dong
Classification Product Code
FRO  
Date Received04/15/2022
Decision Date 01/04/2024
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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