The following data is part of a premarket notification filed by Kowa Company, Ltd. with the FDA for Kowa Sl-19.
| Device ID | K222372 |
| 510k Number | K222372 |
| Device Name: | Kowa SL-19 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu-shi, JP 1820021 |
| Contact | Nariaki Morita |
| Correspondent | Nariaki Morita Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu-shi, JP 1820021 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-05 |
| Decision Date | 2022-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646810070 | K222372 | 000 |
| 04987646810063 | K222372 | 000 |
| 04987646810056 | K222372 | 000 |
| 04987646810049 | K222372 | 000 |
| 04987646810032 | K222372 | 000 |