Topwide Surgical Face Mask

Mask, Surgical

Topwide Medical Products Manufacturer

The following data is part of a premarket notification filed by Topwide Medical Products Manufacturer with the FDA for Topwide Surgical Face Mask.

Pre-market Notification Details

Device IDK210102
510k NumberK210102
Device Name:Topwide Surgical Face Mask
ClassificationMask, Surgical
Applicant Topwide Medical Products Manufacturer 19 Xianhong Road, Xin Li Ren Kou Xiantao,  CN 433012
ContactShoucheng Zhang
CorrespondentJimmy Wu
Lee And Xiao 2600 Mission Street, Suite 206 San Marino,  CA  91108
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-14
Decision Date2021-12-17

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