The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Surgical Face Mask.
| Device ID | K212610 |
| 510k Number | K212610 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Foshan Nanhai Plus Medical CO LTD Shijiang Industrial Zone, Shatou, Jiujiang Town, Nanhai Foshan, CN 528208 |
| Contact | Suyi Li |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-17 |
| Decision Date | 2022-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973062321592 | K212610 | 000 |
| 16973062321493 | K212610 | 000 |
| 16973062321509 | K212610 | 000 |
| 16973062321516 | K212610 | 000 |
| 16973062321523 | K212610 | 000 |
| 16973062321530 | K212610 | 000 |
| 16973062321547 | K212610 | 000 |
| 16973062321554 | K212610 | 000 |
| 16973062321561 | K212610 | 000 |
| 16973062321578 | K212610 | 000 |
| 16973062321585 | K212610 | 000 |
| 16973062321486 | K212610 | 000 |