The following data is part of a premarket notification filed by Shantou T&k Medical Equipment Factory Co.,ltd with the FDA for Medical Surgical Mask.
| Device ID | K210380 |
| 510k Number | K210380 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Shantou T&K Medical Equipment Factory Co.,Ltd No.8 Workshop, Wanji South Second Street Shantou, CN 515065 |
| Contact | Wan Li |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, CN 200071 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-07-08 |