Clearance Summary
KBTC received FDA 510(k) clearance under submission number K950720, sponsored by Kyong-Buk Trading 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 1995-03-01.
- Submission: K950720
- Applicant / Sponsor: Kyong-Buk Trading Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1995-03-01
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.