The following data is part of a premarket notification filed by Mexpo International Inc. with the FDA for Surgical Face Mask.
| Device ID | K200847 |
| 510k Number | K200847 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Mexpo International Inc. 2828 Faber Street Union City, CA 94587 |
| Contact | Tim Thai |
| Correspondent | Tim Thai Mexpo International Inc. 2828 Faber Street Union City, CA 94587 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-04-23 |