Protective Face Mask For Medical Use

Respirator, Surgical

Shandong Shengquan New Material Co., Ltd.

The following data is part of a premarket notification filed by Shandong Shengquan New Material Co., Ltd. with the FDA for Protective Face Mask For Medical Use.

Pre-market Notification Details

Device IDK201537
510k NumberK201537
Device Name:Protective Face Mask For Medical Use
ClassificationRespirator, Surgical
Applicant Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan,  CN 250204
ContactXiumei Zhang
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 Received2020-06-08
Decision Date2020-09-04

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