The following data is part of a premarket notification filed by Kowa Co. Ltd. Chofu with the FDA for Kowa Vk-2s.
| Device ID | K190056 |
| 510k Number | K190056 |
| Device Name: | KOWA VK-2s |
| Classification | System, Image Management, Ophthalmic |
| Applicant | KOWA Co. Ltd. CHOFU 3-1, Chofugaoka 3-chome Chofu, JP 182-0021 |
| Contact | Rinji Kondo |
| Correspondent | Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646808947 | K190056 | 000 |
| 04987646808930 | K190056 | 000 |
| 04987646808923 | K190056 | 000 |