Surgical Face Mask (non-sterile)

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 (non-sterile).

Pre-market Notification Details

Device IDK203426
510k NumberK203426
Device Name:Surgical Face Mask (non-sterile)
ClassificationMask, Surgical
Applicant Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County Nan Tong,  CN 226400
ContactZhang Xuewen
CorrespondentMandy Wu
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-20
Decision Date2021-02-18

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