The following data is part of a premarket notification filed by Heilongjiang Yinjia Medical Equipment Co., Ltd. with the FDA for Disposable Surgical Mask.
|Device Name:||Disposable Surgical Mask|
|Applicant||Heilongjiang Yinjia Medical Equipment Co., Ltd. F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District Harbin, CN 150000|
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|