Disposable Medical Mask

Mask, Surgical

Diasia Biomedical Technology Co., Ltd.

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

Pre-market Notification Details

Device IDK210018
510k NumberK210018
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Diasia Biomedical Technology Co., Ltd. 2F/3F301/4F (Building A) & 2F (Building B), Fuxinlin Industrial Park Shenzhen,  CN 518000
ContactJason Luo
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-04-11

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