510(k) K230841
K230841 is an FDA 510(k) premarket notification submitted by Jps Corporation for the device "NailLift". The FDA issued a decision of Substantially Equivalent on January 22, 2024. The device falls under product code MQZ (Prosthesis, Nail), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2024
- Date Received
- March 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nail
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type