Clearance Summary
FIBER OPTIC ADJUSTABLE HEADLIGHT received FDA 510(k) clearance under submission number K780433, sponsored by Cameron-Miller, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1978-06-13.
- Submission: K780433
- Applicant / Sponsor: Cameron-Miller, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4335
- Decision date: 1978-06-13
Classification & Regulation
This clearance is catalogued under FDA product code FCT and 21 CFR 886.4335, within the Ophthalmic review panel as a Class II device.