The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Konan Noncon Robo Specular Microscope, Models Sp 6000 And Sp 8000.
| Device ID | K950091 |
| 510k Number | K950091 |
| Device Name: | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KONAN MEDICAL, INC. 10-29 MIYANISHI-CHO , NISHINOMIYA Hyogo, JP 662-0976 |
| Contact | George Myers |
| Correspondent | George Myers KONAN MEDICAL, INC. 10-29 MIYANISHI-CHO , NISHINOMIYA Hyogo, JP 662-0976 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-03-01 |
| Summary: | summary |