The following data is part of a premarket notification filed by Jinhua Jingdi Medical Supplies Co., Ltd with the FDA for Face Mask.
| Device ID | K210007 |
| 510k Number | K210007 |
| Device Name: | Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jinhua Jingdi Medical Supplies Co., Ltd Building 2, Ditian Function, Xiaoshun Town, JindongZone Jinhua, CN 321000 |
| Contact | Hu Xiaojiang |
| Correspondent | Julie Chen Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shangha, CN 200040 |
| 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 | 2021-04-23 |