K240817
- 510(k) number
- K240817
- Device name
- VersaWrap
- Applicant
- Alafair Biosciences, Inc. TX · US
- Product code
- OWW — Mesh, Surgical, Absorbable, Orthopaedics, Reinforcem
- Decision date
- 2024-06-14
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240817.pdf
Official FDA record: K240817
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.