K240919
- 510(k) number
- K240919
- Device name
- Silk Voice (SMI-04)
- Applicant
- Sofregen Medical MA · US
- Product code
- MIX — System, Vocal Cord Medialization
- Decision date
- 2024-05-03
- Date received
- 2024-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240919.pdf
Official FDA record: K240919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.