Surgical Mask-Models CR02-2, CR02

Mask, Surgical

Foshan Xinbao Technology Co., Ltd.

The following data is part of a premarket notification filed by Foshan Xinbao Technology Co., Ltd. with the FDA for Surgical Mask-models Cr02-2, Cr02.

Pre-market Notification Details

Device IDK202424
510k NumberK202424
Device Name:Surgical Mask-Models CR02-2, CR02
ClassificationMask, Surgical
Applicant Foshan Xinbao Technology Co., Ltd. No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City Foshan,  CN 528251
ContactWeishan Peng
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou,  CN 510700
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-25
Decision Date2021-03-31

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