Surgical Face Mask

Mask, Surgical

Wuhan Dymex Healthcare Co., Ltd

The following data is part of a premarket notification filed by Wuhan Dymex Healthcare Co., Ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK182515
510k NumberK182515
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Wuhan Dymex Healthcare Co., Ltd Room 1701, Unit 2, Building 5, Jingsegangwan Phase 5, Dongfeng Avenus Wuhan,  CN 430000
ContactAda Liu
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-12
Decision Date2019-05-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840216109022 K182515 000
10840216109015 K182515 000
10840216108995 K182515 000
10840216108971 K182515 000
10840216108964 K182515 000
10840216108940 K182515 000
10840216108735 K182515 000
10840216110929 K182515 000

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