K232238
- 510(k) number
- K232238
- Device name
- Goyo Mouthpiece S
- Applicant
- Dimedikorea KR
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2024-04-17
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232238.pdf
Official FDA record: K232238
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.