HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops— 510(k) K252941
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K252941 for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, Substantially Equivalent on 2025-12-11. Applicant: O&M Halyard, Inc..
Clearance details
- Applicant
- O&M Halyard, Inc.
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, 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.