The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd with the FDA for Medical Surgical Gowns.
|Device Name:||Medical Surgical Gowns|
|Applicant||Beijing Biosis Healing Biological Technology Co., Ltd No.6 Plant West, Valley No.1 Bio-medicine Industry Park, Daxing District, Beijing, CN 102600|
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|