The following data is part of a premarket notification filed by Blackbriar Regulatory Services, Llc with the FDA for Brs Level 1 Face Mask, Brs Level 2 Face Mask.
| Device ID | K202824 |
| 510k Number | K202824 |
| Device Name: | BRS Level 1 Face Mask, BRS Level 2 Face Mask |
| Classification | Mask, Surgical |
| Applicant | Blackbriar Regulatory Services, LLC 820 Southlake Boulevard Richmond, VA 23236 |
| Contact | Vincent Angelico |
| Correspondent | Vincent Angelico Blackbriar Regulatory Services, LLC 820 Southlake Boulevard Richmond, VA 23236 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-03-25 |