The following data is part of a premarket notification filed by Wyz Medical Supplies Llc with the FDA for Wyz Surgical Mask.
| Device ID | K211576 |
| 510k Number | K211576 |
| Device Name: | WYZ Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | WYZ Medical Supplies LLC 5913 Imperial Loop College Station, TX 77845 |
| Contact | Daniel Chen |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-21 |
| Decision Date | 2021-08-19 |