Medical Surgical Mask-Model MP002-5, MP002-6

Mask, Surgical

Jiangmen Sure&Me Medical Product CO., LTD

The following data is part of a premarket notification filed by Jiangmen Sure&me Medical Product Co., Ltd with the FDA for Medical Surgical Mask-model Mp002-5, Mp002-6.

Pre-market Notification Details

Device IDK202577
510k NumberK202577
Device Name:Medical Surgical Mask-Model MP002-5, MP002-6
ClassificationMask, Surgical
Applicant Jiangmen Sure&Me Medical Product CO., LTD Jingshuiwan, Chakeng Village Committee, Huicheng Town, Xinhui District Jiangmen,  CN 529000
ContactLiang Meixia
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou,  CN 510700
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2021-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
26973069130019 K202577 000
26973069130002 K202577 000

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