The following data is part of a premarket notification filed by Taiwan Seafood And Fish Corporation with the FDA for Single-use Surgical Mask.
| Device ID | K211773 |
| 510k Number | K211773 |
| Device Name: | Single-use Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Taiwan Seafood And Fish Corporation 733 Gladys Avenue Los Angeles, CA 90021 |
| Contact | Eric Ly |
| Correspondent | Eric Ly Taiwan Seafood And Fish Corporation 733 Gladys Avenue Los Angeles, CA 90021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-12-02 |