Disposable Face Mask

Mask, Surgical

Jiangsu Excellence Medical Supplies Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Excellence Medical Supplies Co., Ltd with the FDA for Disposable Face Mask.

Pre-market Notification Details

Device IDK202905
510k NumberK202905
Device Name:Disposable Face Mask
ClassificationMask, Surgical
Applicant Jiangsu Excellence Medical Supplies Co., Ltd No.65 Huiling West Road, Zouqu Town, Zhonglou District Changzhou,  CN 203144
ContactJing Zhu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-03-26

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