K241957
- 510(k) number
- K241957
- Device name
- Talee, Talee PostOp
- Applicant
- Invent Medical USA, LLC PA · US
- Product code
- MVA — Orthosis, Cranial
- Decision date
- 2024-08-30
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241957.pdf
Official FDA record: K241957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.