Protective Face Mask For Medical Use

Respirator, Surgical

Hunan Heng Chang Pharmaceutical Co., Ltd.

The following data is part of a premarket notification filed by Hunan Heng Chang Pharmaceutical Co., Ltd. with the FDA for Protective Face Mask For Medical Use.

Pre-market Notification Details

Device IDK202358
510k NumberK202358
Device Name:Protective Face Mask For Medical Use
ClassificationRespirator, Surgical
Applicant Hunan Heng Chang Pharmaceutical Co., Ltd. Floor 2,3, 102 Of Building 16, Standard Plant Of Shanhe Pharmaceutical And Health Changsha,  CN 410000
ContactTao Jingfeng
CorrespondentShelley Li
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai,  CN 200071
Product CodeMSH  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-01-29

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