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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 K210718
Device Name LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd., Dongjiang Hi-Tech Industrial Park
Huizhou,  CN 516005
Applicant Contact Junfeng Zhang
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd., Dongjiang Hi-Tech Industrial Park
Huizhou,  CN 516005
Correspondent Contact Junfeng Zhang
Classification Product Code
FRO  
Date Received03/10/2021
Decision Date 03/23/2022
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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