Single-Use Medical Face Mask

Mask, Surgical

Jiangxi Hongda Medical Equipment Group Co., Ltd.

The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Co., Ltd. with the FDA for Single-use Medical Face Mask.

Pre-market Notification Details

Device IDK210622
510k NumberK210622
Device Name:Single-Use Medical Face Mask
ClassificationMask, Surgical
Applicant Jiangxi Hongda Medical Equipment Group Co., Ltd. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, China Nanchang,  CN 331700
ContactXiaohua Yang
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 Received2021-03-02
Decision Date2021-10-08

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