The following data is part of a premarket notification filed by Wyz Medical Supplies Llc with the FDA for Wyz Surgical Mask.
|Device Name:||WYZ Surgical Mask|
|Applicant||WYZ Medical Supplies LLC 5913 Imperial Loop College Station, TX 77845|
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|