K230495
- 510(k) number
- K230495
- Device name
- Serena Sleep Night Guard
- Applicant
- Meris Investment Group MN · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2023-10-13
- Date received
- 2023-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K230495.pdf
Official FDA record: K230495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.