K243655
- 510(k) number
- K243655
- Device name
- TurbAlign
- Applicant
- Spirair, Inc. Ca · US
- Product code
- LYA — Splint, Intranasal Septal
- Decision date
- 2025-07-11
- Date received
- 2024-11-26
- 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: K243655.pdf
Official FDA record: K243655
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.