Clearance Summary
HALOGEN HEADLIGHT SYSTEM received FDA 510(k) clearance under submission number K810117, sponsored by Colmed, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-02-10.
- Submission: K810117
- Applicant / Sponsor: Colmed, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1981-02-10
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.