The following data is part of a premarket notification filed by Diasia Biomedical Technology Co., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K210018 |
| 510k Number | K210018 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Diasia Biomedical Technology Co., Ltd. 2F/3F301/4F (Building A) & 2F (Building B), Fuxinlin Industrial Park Shenzhen, CN 518000 |
| Contact | Jason Luo |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-04-11 |