The following data is part of a premarket notification filed by Biobase Scientific (shandong) Co., Ltd. with the FDA for Disposable Face Mask.
|Device Name:||Disposable Face Mask|
|Applicant||Biobase Scientific (Shandong) Co., Ltd. No.1777 Dazheng Road, High-Tech District, Jinan City, Shandong Province, China Jinan, CN 250000|
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, CN 200120
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|