The following data is part of a premarket notification filed by Armbrust Inc. with the FDA for American-made Surgical Mask.
| Device ID | K210101 |
| 510k Number | K210101 |
| Device Name: | American-Made Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Armbrust Inc. 3813 Helios Way Building B, Suite 290 Pflugerville, TX 78660 |
| Contact | Landon Morales |
| Correspondent | Landon Morales Armbrust Inc. 3813 Helios Way Building B, Suite 290 Pflugerville, TX 78660 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2022-01-26 |