LUOFUCON PHMB Alginate Dressing (Rx Use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC Use)

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 Phmb Alginate Dressing (rx Use), Luofucon Phmb Antibacterial Alginate Wound Dressing (otc Use).

Pre-market Notification Details

Device IDK201016
510k NumberK201016
Device Name:LUOFUCON PHMB Alginate Dressing (Rx Use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC Use)
ClassificationDressing, Wound, Drug
Applicant Huizhou Foryou Medical Devices Co., Ltd. No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou,  CN 516005
ContactGuosheng Tan
CorrespondentGuosheng Tan
Huizhou Foryou Medical Devices Co., Ltd. No. 1 Shangxia North Road, 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 Received2020-04-17
Decision Date2021-01-28

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.