The following data is part of a premarket notification filed by Unisources Group Llc with the FDA for Disposable Surgical Mask.
| Device ID | K202463 |
| 510k Number | K202463 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Unisources Group LLC 7460 NW 52nd Street Miami, FL 33166 |
| Contact | Henry Shen |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2020-09-18 |