The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Sl-17.
| Device ID | K133755 |
| 510k Number | K133755 |
| Device Name: | KOWA SL-17 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Contact | Hiroyuki Koide |
| Correspondent | Hiroyuki Koide KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646806936 | K133755 | 000 |
| 04987646806929 | K133755 | 000 |
| 04987646806912 | K133755 | 000 |
| 04987646806905 | K133755 | 000 |