K253923
- 510(k) number
- K253923
- Device name
- PuraStat
- Applicant
- 3-D Matrix Europe SAS FR
- Product code
- PHN — Protective Coating, Mucoadhesive Application, For Th
- Decision date
- 2026-01-07
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253923.pdf
Official FDA record: K253923
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.