Clearance Summary
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit received FDA 510(k) clearance under submission number K142956, sponsored by Integrated Healing Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2015-02-24.
- Submission: K142956
- Applicant / Sponsor: Integrated Healing Technologies
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2015-02-24
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.