The following data is part of a premarket notification filed by Macheng Thimble Technology Investment Co., Ltd with the FDA for Surgical Face Mask.
|Device Name:||Surgical Face Mask|
|Applicant||Macheng Thimble Technology Investment Co., Ltd Xiling 2nd Road, Douposhan Village, Macheng Economic Development Zone Huanggang, CN 438000|
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai, CN 200122
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|