Clearance Summary
FRAME, SPECTACLE received FDA 510(k) clearance under submission number K945450, sponsored by Kookje Apis Industrial Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-11-22.
- Submission: K945450
- Applicant / Sponsor: Kookje Apis Industrial Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1994-11-22
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.