Clearance Summary
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE received FDA 510(k) clearance under submission number K801659, sponsored by Coburn Optical Ind., 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 1980-09-09.
- Submission: K801659
- Applicant / Sponsor: Coburn Optical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1980-09-09
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.