The following data is part of a premarket notification filed by Qingdao Hainuo Biological Engineering Co., Ltd. with the FDA for Surgical Mask, Model Name:c015.
| Device ID | K210218 |
| 510k Number | K210218 |
| Device Name: | SURGICAL MASK, Model Name:C015 |
| Classification | Mask, Surgical |
| Applicant | Qingdao Hainuo Biological Engineering Co., Ltd. Industrial Park, Jiangshan Town, Laixi City Qingdao, CN 266000 |
| Contact | Raphael Wang |
| Correspondent | Raphael Wang Qingdao Hainuo Biological Engineering Co., Ltd. Industrial Park, Jiangshan Town, Laixi City Qingdao, CN 266000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2021-05-07 |