K240763
- 510(k) number
- K240763
- Device name
- FirstFit Surgical Kit
- Applicant
- Freudenberg Medical, LLC CA · US
- Product code
- EWL — Prosthesis, Laryngeal (Taub)
- Decision date
- 2024-12-18
- Date received
- 2024-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240763.pdf
Official FDA record: K240763
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.