The following data is part of a premarket notification filed by Ningbo Shun Ye Medical Company, Ltd. with the FDA for Cirx (r) Surgical Mask.
| Device ID | K210256 |
| 510k Number | K210256 |
| Device Name: | CiRx (R) Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Ningbo Shun Ye Medical Company, Ltd. No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo, CN 315313 |
| Contact | Frank Yu |
| Correspondent | Frank Yu Ningbo Shun Ye Medical Company, Ltd. No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo, CN 315313 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-08-19 |