K240286
- 510(k) number
- K240286
- Device name
- PRIMED Surgical Masks and PRIMED Procedure Masks
- Applicant
- Primed Medical Products, Inc. CA
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-08-26
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240286.pdf
Official FDA record: K240286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.