The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K202411 |
| 510k Number | K202411 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Allmed Medical Products Co., Ltd. No. 99, Jin Shan Road, Majiadian Town Zhijiang, CN |
| Contact | Vince Tian |
| 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 | 2020-08-21 |
| Decision Date | 2021-03-10 |