Medical Mask

Mask, Surgical

Zhende Medical Co., Ltd.

The following data is part of a premarket notification filed by Zhende Medical Co., Ltd. with the FDA for Medical Mask.

Pre-market Notification Details

Device IDK210020
510k NumberK210020
Device Name:Medical Mask
ClassificationMask, Surgical
Applicant Zhende Medical Co., Ltd. Gaobu Town, 312035 Shaoxing,  CN 312035
ContactChen Ming
CorrespondentJoyce Yang
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 Received2021-01-04
Decision Date2021-04-28

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