Medical Surgical Masks-Non Sterile

Mask, Surgical

Shandong T&F Nonwoven Co., LTD

The following data is part of a premarket notification filed by Shandong T&f Nonwoven Co., Ltd with the FDA for Medical Surgical Masks-non Sterile.

Pre-market Notification Details

Device IDK202594
510k NumberK202594
Device Name:Medical Surgical Masks-Non Sterile
ClassificationMask, Surgical
Applicant Shandong T&F Nonwoven Co., LTD South Of Shuangyong Road, Chengyang District Qingdao,  CN 266100
ContactMinsheng Zhao
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2021-01-06

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