The following data is part of a premarket notification filed by Topcon Corporation with the FDA for Sp-1pspecular Microscope.
| Device ID | K142417 |
| 510k Number | K142417 |
| Device Name: | SP-1PSpecular Microscope |
| Classification | Microscope, Specular |
| Applicant | TOPCON CORPORATION 75-1 Hasunuma-Cho, Itabashi-ku Tokyo, JP 174-8580 |
| Contact | Michael Gusel |
| Correspondent | Ryan Bouchard ORA 300 BRICKSTONE SQUARE Andover, MA 01810 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2015-05-29 |
| Summary: | summary |