K232059
- 510(k) number
- K232059
- Device name
- Tympanostomy Tubes
- Applicant
- Grace Medical, Inc. TN · US
- Product code
- ETD — Tube, Tympanostomy
- Decision date
- 2023-11-24
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232059.pdf
Official FDA record: K232059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.