The following data is part of a premarket notification filed by Byd Precison Manufacturer Co., Ltd. with the FDA for Single-use Surgical Mask Model Fe2311b.
| Device ID | K210970 |
| 510k Number | K210970 |
| Device Name: | Single-Use Surgical Mask Model FE2311B |
| Classification | Mask, Surgical |
| Applicant | BYD Precison Manufacturer Co., Ltd. No.3001 Baohe Road, Baolong Industrial Area, Longgang Shenzhen, CN 518116 |
| Contact | Yubo Guan |
| Correspondent | Jenny Jing Global Healthcare Product Solutions, LLC 1800 S. Figueroa St. Los Angeles, CA 90015 -3422 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2021-07-21 |