K251902
- 510(k) number
- K251902
- Device name
- Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
- Applicant
- Vitacore Industries, Inc. CA
- Product code
- FXX — Mask, Surgical
- Decision date
- 2025-09-17
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K251902.pdf
Official FDA record: K251902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.