The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Livocare Surgical Mask.
| Device ID | K201380 |
| 510k Number | K201380 |
| Device Name: | Livocare Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin, CN 300190 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2020-10-07 |