Surgical Face Mask

Mask, Surgical

Guangdong Winsun Personal Care Products Co.,Ltd

The following data is part of a premarket notification filed by Guangdong Winsun Personal Care Products Co.,ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK210023
510k NumberK210023
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Guangdong Winsun Personal Care Products Co.,Ltd No.1 Guangxing Road, Xiqiao Sci-Tec Industrial Park, Xiqiao Town Foshan,  CN 528200
ContactDong Pingping
CorrespondentGrace Liu
Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-04-02

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