Medical Surgical Mask

Mask, Surgical

Tianjin Aoshang Outdoor Equipment Co., Ltd.

The following data is part of a premarket notification filed by Tianjin Aoshang Outdoor Equipment Co., Ltd. with the FDA for Medical Surgical Mask.

Pre-market Notification Details

Device IDK210030
510k NumberK210030
Device Name:Medical Surgical Mask
ClassificationMask, Surgical
Applicant Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin Tianjin,  CN 300133
ContactXiaoning Zhang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-05
Decision Date2021-04-23

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