Disposable Surgical Face Mask

Mask, Surgical

Guangdong Bida Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Guangdong Bida Medical Technology Co., Ltd. with the FDA for Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK202387
510k NumberK202387
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Guangdong Bida Medical Technology Co., Ltd. No.2, Xingfeng Rd, Shangsha Zhenxing District Chang'an Town, Dongguan City Dongguan,  CN 523843
ContactZhang Rong
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guang Guangzhou,  CN 510700
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-04-23

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