K233658
- 510(k) number
- K233658
- Device name
- Biowy Tym Tube (TT)
- Applicant
- Biowy Corporation CA · US
- Product code
- ETD — Tube, Tympanostomy
- Decision date
- 2024-02-16
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K233658.pdf
Official FDA record: K233658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.