The following data is part of a premarket notification filed by Conod Medical Co., Limited with the FDA for Single-use Medical Face Mask.
|Device Name:||Single-use Medical Face Mask|
|Applicant||Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu, CN 215532|
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|