Surgical Mask

Mask, Surgical

Jiangsu Xingtong Biotechnology Group Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Xingtong Biotechnology Group Co., Ltd. with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK211454
510k NumberK211454
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Jiangsu Xingtong Biotechnology Group Co., Ltd. No.8, Kele Road, Touqiao Area, Beizhou Industrial Park, Guangling Zone Yangzhou,  CN 225000
ContactLi Hua
CorrespondentJames Tsai
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2021-08-18

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