The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Konan Specular Microscope Xvii.
| Device ID | K191558 |
| 510k Number | K191558 |
| Device Name: | Konan Specular Microscope XVII |
| Classification | Microscope, Specular |
| Applicant | Konan Medical, Inc. 10-29, Miyanishicho Nishinomiya, JP 662-0976 |
| Contact | Tatsuya Kasahara |
| Correspondent | Alan Donald MATRIX MEDICAL CONSULTING INC 8880 Rio San Diego Drive Suite 800 San Diego, CA 92108 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250626 | K191558 | 000 |
| 04582275250664 | K191558 | 000 |
| 04582275250671 | K191558 | 000 |