K202824 is an FDA 510(k) clearance for the BRS Procedure Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Blackbriar Regulatory Services, LLC (Richmond, US). The FDA issued a Cleared decision on March 25, 2021, 182 days after receiving the submission on September 24, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 182 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |