The following data is part of a premarket notification filed by Tianjin Aoshang Outdoor Equipment Co., Ltd. with the FDA for Medical Surgical Mask.
|Device Name:||Medical Surgical Mask|
|Applicant||Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin Tianjin, CN 300133|
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|