Disposable Medical Mask

Mask, Surgical

Anhui JBH Medical Apparatus Co., Ltd.

The following data is part of a premarket notification filed by Anhui Jbh Medical Apparatus Co., Ltd. with the FDA for Disposable Medical Mask.

Pre-market Notification Details

Device IDK210302
510k NumberK210302
Device Name:Disposable Medical Mask
ClassificationMask, Surgical
Applicant Anhui JBH Medical Apparatus Co., Ltd. No. 116 Qicang Road, Mingguang City Chuzhou,  CN 239400
ContactDandan Yang
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-05-14

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