Naton Disposable Surgical Face Mask

Mask, Surgical

Naton Biotechnology (Beijing) Co., Ltd.

The following data is part of a premarket notification filed by Naton Biotechnology (beijing) Co., Ltd. with the FDA for Naton Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK201853
510k NumberK201853
Device Name:Naton Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Naton Biotechnology (Beijing) Co., Ltd. No. 9, Chengwan Street, Haidian District Beijing,  CN 100094
ContactShanshan Zou
CorrespondentShanshan Zou
Naton Biotechnology (Beijing) Co., Ltd. No. 9, Chengwan Street, Haidian District Beijing,  CN 100094
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2021-04-23

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.