Medical Face Mask

Mask, Surgical

Gemtier Medical (Shanghai) Inc

The following data is part of a premarket notification filed by Gemtier Medical (shanghai) Inc with the FDA for Medical Face Mask.

Pre-market Notification Details

Device IDK202493
510k NumberK202493
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Gemtier Medical (Shanghai) Inc No.18 Jianding Road, Fengjing Town, Jinshan District Shanghai,  CN 201502
ContactLi Zhiqing
CorrespondentJulie Chen
Shanghai Medical Business Consulting Co., Ltd. No. 170 Huajiang Road, Jiading District Shanghai,  CN 201803
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-02-04

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