K232820
- 510(k) number
- K232820
- Device name
- HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
- Applicant
- Owens & Minor (O&M) Halyard, Inc. VA · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-06-04
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232820.pdf
Official FDA record: K232820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.