Face Mask

Mask, Surgical

Jinhua Jingdi Medical Supplies Co., Ltd

The following data is part of a premarket notification filed by Jinhua Jingdi Medical Supplies Co., Ltd with the FDA for Face Mask.

Pre-market Notification Details

Device IDK210007
510k NumberK210007
Device Name:Face Mask
ClassificationMask, Surgical
Applicant Jinhua Jingdi Medical Supplies Co., Ltd Building 2, Ditian Function, Xiaoshun Town, JindongZone Jinhua,  CN 321000
ContactHu Xiaojiang
CorrespondentJulie Chen
Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shangha,  CN 200040
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-04-23

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