HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)— 510(k) K232820
Substantially EquivalentOwens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearance K232820 for HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806), Substantially Equivalent on 2024-06-04. Applicant: Owens & Minor (O&M) Halyard, Inc..
Clearance details
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mechanicsville, 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.