Disposable Medical Face Mask

Mask, Surgical

Zhejiang Senhong Medical&Instrument Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Senhong Medical&instrument Co., Ltd. with the FDA for Disposable Medical Face Mask.

Pre-market Notification Details

Device IDK202676
510k NumberK202676
Device Name:Disposable Medical Face Mask
ClassificationMask, Surgical
Applicant Zhejiang Senhong Medical&Instrument Co., Ltd. Floor 1-2, Building 2, No 889 North Huancheng Rd, Fu'xi Subdistrict, Deqing County Huzhou,  CN 313200
ContactEric Jian
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2021-11-05

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