BRS Procedure Face Mask— 510(k) K202824
Substantially EquivalentBlackbriar Regulatory Services, LLC
FDA 510(k) clearance K202824 for BRS Procedure Face Mask, Substantially Equivalent on 2021-03-25. Applicant: Blackbriar Regulatory Services, LLC.
Clearance details
- Applicant
- Blackbriar Regulatory Services, LLC
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Richmond, VA, US
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.