The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Biophtal Clinical Endothelial Microscope.
| Device ID | K801659 |
| 510k Number | K801659 |
| Device Name: | BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-21 |
| Decision Date | 1980-09-09 |