The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Slit Lamp Sl-d301.
| Device ID | K161972 |
| 510k Number | K161972 |
| Device Name: | Slit Lamp SL-D301 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TOPCON CORPORATION 75-1 HASUNUMA-CHO, ITABASHIL-KU Tokyo, JP 174-8580 |
| Contact | Michael Gusel |
| Correspondent | Maureen O'connell O'CONNELL REGULATORY CONSULTANTS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-12-09 |
| Summary: | summary |