The following data is part of a premarket notification filed by Xiamen Probtain Medical Techology Co., Ltd with the FDA for Disposable Surgical Mask.
|Device Name:||Disposable Surgical Mask|
|Applicant||Xiamen Probtain Medical Techology Co., Ltd 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen, CN 361100|
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|