The following data is part of a premarket notification filed by Excellent Medical Technology Group Co., Ltd. with the FDA for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-sterile.
|Device Name:||Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile|
|Applicant||Excellent Medical Technology Group Co., Ltd. Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road Suzhou, CN 215131|
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|