Disposable Surgical Mask (non Sterile)

Mask, Surgical

Qinhuangdao Taizhi Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Qinhuangdao Taizhi Medical Technology Co., Ltd. with the FDA for Disposable Surgical Mask (non Sterile).

Pre-market Notification Details

Device IDK211451
510k NumberK211451
Device Name:Disposable Surgical Mask (non Sterile)
ClassificationMask, Surgical
Applicant Qinhuangdao Taizhi Medical Technology Co., Ltd. No.5, Small And Medium Enterprises Incubator Base, East Circular Economy Park, Haigang District Qinhuangdao,  CN 066000
ContactFan Xifan
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2021-08-25

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