Medical Surgical Mask

Mask, Surgical

Shantou T&K Medical Equipment Factory Co.,Ltd

The following data is part of a premarket notification filed by Shantou T&k Medical Equipment Factory Co.,ltd with the FDA for Medical Surgical Mask.

Pre-market Notification Details

Device IDK210380
510k NumberK210380
Device Name:Medical Surgical Mask
ClassificationMask, Surgical
Applicant Shantou T&K Medical Equipment Factory Co.,Ltd No.8 Workshop, Wanji South Second Street Shantou,  CN 515065
ContactWan Li
CorrespondentStuart Situ
Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai,  CN 200071
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-07-08

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