Banded Face Mask

Mask, Surgical

Hubei Medlink Healthcare Co., Ltd

The following data is part of a premarket notification filed by Hubei Medlink Healthcare Co., Ltd with the FDA for Banded Face Mask.

Pre-market Notification Details

Device IDK223003
510k NumberK223003
Device Name:Banded Face Mask
ClassificationMask, Surgical
Applicant Hubei Medlink Healthcare Co., Ltd 36F, Tower1, New World International Trade Tower 568 Jianshe Avenue Wuhan,  CN 430000
ContactNiki Wang
CorrespondentCheng Luo
CL 3D Devices LLC 10420 Overgate Place Potomac,  MD  20854
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-29
Decision Date2022-11-18

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