Single-use Medical Face Mask

Mask, Surgical

Conod Medical Co., Limited

The following data is part of a premarket notification filed by Conod Medical Co., Limited with the FDA for Single-use Medical Face Mask.

Pre-market Notification Details

Device IDK203591
510k NumberK203591
Device Name:Single-use Medical Face Mask
ClassificationMask, Surgical
Applicant Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu,  CN 215532
ContactCarrie Wu
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou,  CN 510006
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-08
Decision Date2021-07-02

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