The following data is part of a premarket notification filed by Tianchang Kanghui Protective Products Co Ltd with the FDA for Surgical Mask.
|Device Name:||Surgical Mask|
|Applicant||Tianchang Kanghui Protective Products CO LTD No.16 Wayeconomic Development Zone Tianchan, CN 293900|
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|