The following data is part of a premarket notification filed by The Aleen International Corporation with the FDA for Aic Disposable Medical Mask.
| Device ID | K203775 |
| 510k Number | K203775 |
| Device Name: | AIC Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | The Aleen International Corporation Jiutian Green Science And Technology Industrial Park, Heyuan High-Tech Zone Heyuan, CN 517000 |
| Contact | Can Huang |
| Correspondent | Diana Lam Duocare, LLC 370 W. Grand Blvd, Suite 110 Corona, CA 92882 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-03-12 |