The following data is part of a premarket notification filed by Anhui Medpurest Medical Technology Co.,ltd with the FDA for Disposable Surgical Gowns.
|Device Name:||Disposable Surgical Gowns|
|Applicant||Anhui Medpurest Medical Technology Co.,Ltd No.188,Wenyuan Road, Zhumeng New Zone Anqing, CN 246003|
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, CN 200122
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|