The following data is part of a premarket notification filed by Juntech(jiaxing)healthcare Materials Co,.ltd with the FDA for Surgical Face Mask.
|Device Name:||Surgical Face Mask|
|Applicant||Juntech(Jiaxing)Healthcare Materials Co,.Ltd No.4 Plant,No1 Build Of North Of Yubei St, And Zhengdong Rd, Yuxin Town Nanhu District Jiaxing, CN 314009|
Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, CN 510000
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|