Procedure Mask with Ear Loops and Surgical Mask with Ties— 510(k) K221134
Substantially EquivalentSafesource Direct, LLC
FDA 510(k) clearance K221134 for Procedure Mask with Ear Loops and Surgical Mask with Ties, Substantially Equivalent on 2022-05-19. Applicant: Safesource Direct, LLC.
Clearance details
- Applicant
- Safesource Direct, LLC
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Broussard, LA, 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.