The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd with the FDA for Allmed Surgical Face Masks (ear Loops).
|Device Name:||Allmed Surgical Face Masks (Ear Loops)|
|Applicant||Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200|
Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|