Clearance Summary
CUSTOM ARTIFICIAL HUMAN EYES received FDA 510(k) clearance under submission number K945270, sponsored by Daniel T Acosta. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-05-30.
- Submission: K945270
- Applicant / Sponsor: Daniel T Acosta
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.3200
- Decision date: 1995-05-30
Classification & Regulation
This clearance is catalogued under FDA product code HQH and 21 CFR 886.3200, within the Ophthalmic review panel as a Class I device.