Clearance Summary
BD K-4000 MICROKERATOME SYSTEM received FDA 510(k) clearance under submission number K023092, sponsored by Becton, Dickinson & CO. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-10-18.
- Submission: K023092
- Applicant / Sponsor: Becton, Dickinson & CO
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2002-10-18
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.