Clearance Summary
CureOs TCP received FDA 510(k) clearance under submission number K191670, sponsored by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-08-04.
- Submission: K191670
- Applicant / Sponsor: Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2020-08-04
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.