The following data is part of a premarket notification filed by Zhende Medical Co., Ltd. with the FDA for Medical Mask.
| Device ID | K210020 |
| 510k Number | K210020 |
| Device Name: | Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Zhende Medical Co., Ltd. Gaobu Town, 312035 Shaoxing, CN 312035 |
| Contact | Chen Ming |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-04-28 |