Disposable Medical Mask

Mask, Surgical

Yangzhou Runyi Arts & Crafts CO., LTD.

The following data is part of a premarket notification filed by Yangzhou Runyi Arts & Crafts Co., Ltd. with the FDA for Disposable Medical Mask.

Pre-market Notification Details

Device IDK203112
510k NumberK203112
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Yangzhou Runyi Arts & Crafts CO., LTD. 4. NO.87 West Heye Road HanJiang District Yangzhou,  CN 225008
ContactLi Yu
CorrespondentHelen Nan
Wenzhou Cytech Information Service Co., Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou,  CN 32500
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-15
Decision Date2021-09-16

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