K231865
- 510(k) number
- K231865
- Device name
- Mouth Guard (ATG0603R)
- Applicant
- Reazeal Corp DE · US
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2023-11-06
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231865.pdf
Official FDA record: K231865
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.