The following data is part of a premarket notification filed by Foshan Xinbao Technology Co., Ltd. with the FDA for Surgical Mask-models Cr02-2, Cr02.
| Device ID | K202424 |
| 510k Number | K202424 |
| Device Name: | Surgical Mask-Models CR02-2, CR02 |
| Classification | Mask, Surgical |
| Applicant | Foshan Xinbao Technology Co., Ltd. No. 20 Changjiang Road, Sanshan New Town, Nanhai District, Foshan City Foshan, CN 528251 |
| Contact | Weishan Peng |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510700 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2021-03-31 |