The following data is part of a premarket notification filed by Xiamen Probtain Medical Techology Co., Ltd with the FDA for Disposable Surgical Mask.
| Device ID | K202954 |
| 510k Number | K202954 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Xiamen Probtain Medical Techology Co., Ltd 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen, CN 361100 |
| Contact | Jianli Kang |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue 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 | 2020-09-30 |
| Decision Date | 2021-07-02 |