Medical Face Masks

Mask, Surgical

Guilin HBM Sanitary Protections, Inc

The following data is part of a premarket notification filed by Guilin Hbm Sanitary Protections, Inc with the FDA for Medical Face Masks.

Pre-market Notification Details

Device IDK202627
510k NumberK202627
Device Name:Medical Face Masks
ClassificationMask, Surgical
Applicant Guilin HBM Sanitary Protections, Inc No.1-2, Shuijing East Road, Economic And Technological Development Area Guilin,  CN 541805
ContactLiu Xin
CorrespondentShelley Li
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai,  CN 200071
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-02-03

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