K240258
- 510(k) number
- K240258
- Device name
- Disposable Medical Face Mask (M643BE)
- Applicant
- Makrite Industries, Inc. TW
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-04-18
- Date received
- 2024-01-31
- 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: K240258.pdf
Official FDA record: K240258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.