Surgical Face Mask

Mask, Surgical

Nantong Taiweishi Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Nantong Taiweishi Medical Technology Co., Ltd. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK212264
510k NumberK212264
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County Nantong,  CN 226400
ContactZhang Xuewen
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2021-11-13

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