LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

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 Extra Silver Alginate Dressing, Luofucon Extra Antibacterial Alginate Dressing.

Pre-market Notification Details

Device IDK172554
510k NumberK172554
Device Name:LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
ClassificationDressing, Wound, Drug
Applicant Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
ContactHuida Huang
CorrespondentHuida 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 Received2017-08-24
Decision Date2018-05-01
Summary:summary

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