Clearance Summary
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ received FDA 510(k) clearance under submission number K994340, sponsored by Hai Laboratories, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-09-20.
- Submission: K994340
- Applicant / Sponsor: Hai Laboratories, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2000-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HLI and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.