Disposable Surgical Face Mask

Mask, Surgical

Jiangxi Heying Pharmaceutical Co., Ltd

The following data is part of a premarket notification filed by Jiangxi Heying Pharmaceutical Co., Ltd with the FDA for Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK210429
510k NumberK210429
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Jiangxi Heying Pharmaceutical Co., Ltd Huangjinbu Town, Yugan County Shangrao,  CN 335100
ContactJunzheng Liu
CorrespondentMandy Wu
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-12
Decision Date2021-06-02

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