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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 K201016
Device Name LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
#1 Shangxia N. Rd., Dongjiang Hi-Tech Industry Park,
Huizhou,  CN 516005
Applicant Contact Guosheng Tan
Correspondent
Huizhou Foryou Medical Devices Co., Ltd.
#1 Shangxia N. Rd., Dongjiang Hi-Tech Industry Park,
Huizhou,  CN 516005
Correspondent Contact Guosheng Tan
Classification Product Code
FRO  
Date Received04/17/2020
Decision Date 01/28/2021
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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