The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowagenesis-df.
| Device ID | K091098 |
| 510k Number | K091098 |
| Device Name: | KOWAGENESIS-DF |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Contact | Akihiro Gujita |
| Correspondent | Akihiro Gujita 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646800583 | K091098 | 000 |