The following data is part of a premarket notification filed by Sichuan Prius Biotechnology Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K210908 |
| 510k Number | K210908 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Sichuan Prius Biotechnology Co., Ltd. No.2 Prius Road, Luo Long Industrial Park Nanxi District Yibin, CN 644104 |
| Contact | Yan Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-09-26 |