The following data is part of a premarket notification filed by Shenzhen Jinko Industrial Co., Ltd with the FDA for Disposable Medical Face Mask-model Fm-04.
| Device ID | K202513 |
| 510k Number | K202513 |
| Device Name: | Disposable Medical Face Mask-Model FM-04 |
| Classification | Mask, Surgical |
| Applicant | Shenzhen Jinko Industrial Co., Ltd Building B2 101, Haocheng (Heping) Industrial Park, No. 66 Hexiu West Road Shenzhen, CN 518100 |
| Contact | Wang Yinghui |
| 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 | 2020-08-31 |
| Decision Date | 2021-04-09 |