Surgical Face Mask

Mask, Surgical

Wanxinda (Guangzhou) Technology Product Co., Ltd

The following data is part of a premarket notification filed by Wanxinda (guangzhou) Technology Product Co., Ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK202548
510k NumberK202548
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Wanxinda (Guangzhou) Technology Product Co., Ltd Ling Xi Road, Accessory Section 2, Automobile Zone, Huada District Guangzhou,  CN 510800
ContactZeng Xueping
CorrespondentJoyce No Last Name Provided
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518100
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-02
Decision Date2021-03-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945015300032 K202548 000
06945015300018 K202548 000

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