The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Genesis-d.
| Device ID | K080681 |
| 510k Number | K080681 |
| Device Name: | KOWA GENESIS-D |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Contact | Satohiko Takanashi |
| Correspondent | Satohiko Takanashi KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-04-04 |
| Summary: | summary |