Surgical Face Mask

Mask, Surgical

Juntech(Jiaxing)Healthcare Materials Co,.Ltd

The following data is part of a premarket notification filed by Juntech(jiaxing)healthcare Materials Co,.ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK203704
510k NumberK203704
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Juntech(Jiaxing)Healthcare Materials Co,.Ltd No.4 Plant,No1 Build Of North Of Yubei St, And Zhengdong Rd, Yuxin Town Nanhu District Jiaxing,  CN 314009
ContactCam Sun
CorrespondentGamma Zhang
Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou,  CN 510000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-06-04

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