The following data is part of a premarket notification filed by Wellmed Dental Medical Supply Co., Ltd. with the FDA for Disposable Medical Face Mask (df3-001).
|Device Name:||Disposable Medical Face Mask (DF3-001)|
|Applicant||Wellmed Dental Medical Supply Co., Ltd. 301 Zhongxing Science And Technology Building,No.64, Xin’an 2nd Road, Baoan District Shenzhen, CN|
Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai, CN 200122
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|