The following data is part of a premarket notification filed by Zhengzhou Huaer Electro Optics Technology Co., Ltd with the FDA for Impression Material.
| Device ID | K201483 |
| 510k Number | K201483 |
| Device Name: | Impression Material |
| Classification | Material, Impression |
| Applicant | Zhengzhou Huaer Electro Optics Technology Co., Ltd Floor 1, B Of Building 18, National University Science Park of Henan Province Zhengzhou, CN 450000 |
| Contact | Li Xiaojun |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2020-10-08 |