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 |