K250869
- 510(k) number
- K250869
- Device name
- Parietene Macroporous Mesh (PPM5050 )
- Applicant
- Sofradim Production FR
- Product code
- FTL — Mesh, Surgical, Polymeric
- Decision date
- 2025-04-23
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250869.pdf
Official FDA record: K250869
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.