Clearance Summary
FITE FIXATION TOY FOR OCULAR EXAM received FDA 510(k) clearance under submission number K801381, sponsored by Fite Engineering Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-07-28.
- Submission: K801381
- Applicant / Sponsor: Fite Engineering Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1290
- Decision date: 1980-07-28
Classification & Regulation
This clearance is catalogued under FDA product code HPL and 21 CFR 886.1290, within the Ophthalmic review panel as a Class I device.