Clearance Summary
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME received FDA 510(k) clearance under submission number K022637, sponsored by Becton, Dickinson & 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 2002-10-16.
- Submission: K022637
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2002-10-16
Classification & Regulation
This clearance is catalogued under FDA product code HMY and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.