K241957

Talee, Talee PostOp

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.