Clearance Summary
FIBEROPTIC HEADLIGHT SYSTEM received FDA 510(k) clearance under submission number K893458, sponsored by Cuda Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-06-22.
- Submission: K893458
- Applicant / Sponsor: Cuda Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1989-06-22
Classification & Regulation
This clearance is catalogued under FDA product code EBA and 21 CFR 872.4630, within the Dental review panel as a Class I device.