Clearance Summary
MILLENIUM MICROKERATOME, MODEL IMD-001 received FDA 510(k) clearance under submission number K992687, sponsored by Industrial & Medical Design, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-09-24.
- Submission: K992687
- Applicant / Sponsor: Industrial & Medical Design, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1999-09-24
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.