The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd with the FDA for Disposable Medical Surgical Mask.
|Device Name:||Disposable Medical Surgical Mask|
|Applicant||Hebei Titans Hongsen Medical Technology Co., LTD Eastern Industrial Concentration Zone, Nangong City Xingtai, CN 055750|
Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|