Medical Face Mask

Mask, Surgical

Jiangsu Province Jianerkang Medical Dressing Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Province Jianerkang Medical Dressing Co., Ltd with the FDA for Medical Face Mask.

Pre-market Notification Details

Device IDK202061
510k NumberK202061
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou,  CN 213251
ContactHongfang Tang
CorrespondentHongfang Tang
Jiangsu Province Jianerkang Medical Dressing Co., Ltd No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou,  CN 213251
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2020-12-23

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