Disposable Surgical Mask

Mask, Surgical

Heilongjiang Yinjia Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Heilongjiang Yinjia Medical Equipment Co., Ltd. with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK212944
510k NumberK212944
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Heilongjiang Yinjia Medical Equipment Co., Ltd. F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District Harbin,  CN 150000
ContactZhu Hongwei
CorrespondentDoris Dong
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai,  CN 201613
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-13
Decision Date2021-12-15

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