The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa, Fm-600, Model Lss50.
| Device ID | K091039 |
| 510k Number | K091039 |
| Device Name: | KOWA, FM-600, MODEL LSS50 |
| Classification | Ophthalmoscope, Laser, Scanning |
| 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 | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646804024 | K091039 | 000 |