K232293
- 510(k) number
- K232293
- Device name
- kallisio stentra oral stent
- Applicant
- Kallisio, Inc. TX · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2023-12-22
- Date received
- 2023-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K232293.pdf
Official FDA record: K232293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.