LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

Dressing, Wound, Drug

Huizhou Foryou Medical Devices CO., Ltd.

The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Silver Wound Gel, Luofucon Silver Antimicrobial Wound Gel.

Pre-market Notification Details

Device IDK211123
510k NumberK211123
Device Name:LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
ClassificationDressing, Wound, Drug
Applicant Huizhou Foryou Medical Devices CO., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
ContactHuiqi Huang
CorrespondentHuiqi Huang
Huizhou Foryou Medical Devices CO., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-04-15
Decision Date2022-04-22

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