The following data is part of a premarket notification filed by Rizhao Sanqi Medical & Health Articles Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K202903 |
| 510k Number | K202903 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Rizhao Sanqi Medical & Health Articles Co., Ltd. Heshan Industry Park, Donggang Distric Rizhao, CN 276823 |
| Contact | Julia Yu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2022-03-24 |