Clearance Summary
PELICAN BAY KEL-COR CEPHALOMETRIC SYS. received FDA 510(k) clearance under submission number K791916, sponsored by Pelican Bay Kel-Cor. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1979-11-05.
- Submission: K791916
- Applicant / Sponsor: Pelican Bay Kel-Cor
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1979-11-05
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.