K233999
- 510(k) number
- K233999
- Device name
- GalaFLEX LITE Scaffold
- Applicant
- Tepha, Inc. MA · US
- Product code
- OOD — Surgical Film
- Decision date
- 2024-04-09
- Date received
- 2023-12-18
- 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: K233999.pdf
Official FDA record: K233999
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.