The following data is part of a premarket notification filed by Topwide Medical Products Manufacturer with the FDA for Topwide Surgical Face Mask.
| Device ID | K210102 |
| 510k Number | K210102 |
| Device Name: | Topwide Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Topwide Medical Products Manufacturer 19 Xianhong Road, Xin Li Ren Kou Xiantao, CN 433012 |
| Contact | Shoucheng Zhang |
| Correspondent | Jimmy Wu Lee And Xiao 2600 Mission Street, Suite 206 San Marino, CA 91108 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2021-12-17 |