Medical 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 Medical Face Mask.

Pre-market Notification Details

Device IDK214087
510k NumberK214087
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Hubei Medlink Healthcare Co., Ltd 36F, Tower1, New World International Trade Tower 568 Jianshe Avenue Wuhan,  CN 430000
ContactSophie Liu
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10853927007730 K214087 000
20850044799798 K214087 000

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