Surgical Face Mask

Mask, Surgical

Jiangxi 3L Medical Products Group Co., Ltd

The following data is part of a premarket notification filed by Jiangxi 3l Medical Products Group Co., Ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK202277
510k NumberK202277
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone Nanchang City,  CN 330029
ContactGe Zhang
CorrespondentCharles Mack
IRC 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-11
Decision Date2020-09-25

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