The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd. with the FDA for Surgical Mask.
|Device Name:||Surgical Mask|
|Applicant||Allmed Medical Products Co., Ltd. No. 99, Jin Shan Road, Majiadian Town Zhijiang, CN|
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|