K233569
- 510(k) number
- K233569
- Device name
- SeptAlign
- Applicant
- Spirair, Inc. Ca · US
- Product code
- NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Decision date
- 2024-03-22
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233569.pdf
Official FDA record: K233569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.