Disposable Medical Mask

Mask, Surgical

Everwin Toys (Dongguan)., Ltd.

The following data is part of a premarket notification filed by Everwin Toys (dongguan)., Ltd. with the FDA for Disposable Medical Mask.

Pre-market Notification Details

Device IDK203388
510k NumberK203388
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Everwin Toys (Dongguan)., Ltd. Xiekeng Village, Qingxi Town Dongguan,  CN 523000
ContactHuang Zibin
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou,  CN 510700
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-18
Decision Date2021-06-04

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