The following data is part of a premarket notification filed by Hunan Triplex Precision Medical Devices Co., Ltd with the FDA for Surgical Masks, Model:fe-1.
| Device ID | K210767 |
| 510k Number | K210767 |
| Device Name: | Surgical Masks, Model:FE-1 |
| Classification | Mask, Surgical |
| Applicant | Hunan Triplex Precision Medical Devices Co., Ltd Room 612 & 613, Building No.5~8, SUNVO Health & Medicine Industrial Park, Changsha, CN 410153 |
| Contact | Huang Kai |
| Correspondent | Amber Pang Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Shanghai, CN 200072 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-06-10 |