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 |