Disposable Medical Mask

Mask, Surgical

Hubei Wanli Protective Products Co., Ltd.

The following data is part of a premarket notification filed by Hubei Wanli Protective Products Co., Ltd. with the FDA for Disposable Medical Mask.

Pre-market Notification Details

Device IDK210150
510k NumberK210150
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Hubei Wanli Protective Products Co., Ltd. Yuanshi, Ganhe Xiantao,  CN 433000
ContactAndy Wen
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-06-02

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