Surgical Face Mask

Mask, Surgical

RFX+CARE Manufactoring Co., Ltd.

The following data is part of a premarket notification filed by Rfx+care Manufactoring Co., Ltd. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK203190
510k NumberK203190
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant RFX+CARE Manufactoring Co., Ltd. 7 Lanjiang Road, Yuecheng District Shao Xing,  CN 312000
ContactZhou Xiufeng
CorrespondentJames Tsai
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-27
Decision Date2021-06-02

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