Disposable Medical Face Mask-Model FM-04

Mask, Surgical

Shenzhen Jinko Industrial Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Jinko Industrial Co., Ltd with the FDA for Disposable Medical Face Mask-model Fm-04.

Pre-market Notification Details

Device IDK202513
510k NumberK202513
Device Name:Disposable Medical Face Mask-Model FM-04
ClassificationMask, Surgical
Applicant Shenzhen Jinko Industrial Co., Ltd Building B2 101, Haocheng (Heping) Industrial Park, No. 66 Hexiu West Road Shenzhen,  CN 518100
ContactWang Yinghui
CorrespondentJoyce Yang
Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen,  CN 518100
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-04-09

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