510(k) K230495
K230495 is an FDA 510(k) premarket notification submitted by Meris Investment Group for the device "Serena Sleep Night Guard". The FDA issued a decision of Substantially Equivalent on October 13, 2023. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Meris Investment Group has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2023
- Date Received
- February 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type