K232806
- 510(k) number
- K232806
- Device name
- HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
- Applicant
- Owens & Minor (O&M) Halyard, Inc. VA · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-06-07
- Date received
- 2023-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K232806.pdf
Official FDA record: K232806
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.