The following data is part of a premarket notification filed by Hunan Zhenheyikang Medical Instrument Co., Ltd with the FDA for Medical Surgical Mask.
| Device ID | K213724 |
| 510k Number | K213724 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Hunan Zhenheyikang Medical Instrument Co., Ltd No.6 Building Jingxiang Energy,No.55 Xiaguang East Road, Gaoxin District Xiangtan, CN 411100 |
| Contact | Yilin Yin |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-26 |
| Decision Date | 2022-02-20 |