K231719
- 510(k) number
- K231719
- Device name
- Medical Surgical Mask
- Applicant
- Azur Medical Company, Inc. VA · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-03-19
- Date received
- 2023-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231719.pdf
Official FDA record: K231719
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.