The following data is part of a premarket notification filed by Feng Chun Yuan Medical Equipment (shenzhen) Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K210225 |
| 510k Number | K210225 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd Room 1304, Technology Innovation Park, Shajing Dahong (Xinqiao), Baoan District Shenzhen, CN 518000 |
| Contact | Qiyuan Ning |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-03-04 |