The following data is part of a premarket notification filed by Tomey Corporation with the FDA for Em-4000 Specular Microscope.
| Device ID | K171313 |
| 510k Number | K171313 |
| Device Name: | EM-4000 Specular Microscope |
| Classification | Microscope, Specular |
| Applicant | Tomey Corporation 2-11-33 Noritakeshinmachi Nishiku Nagoya, JP 4510051 |
| Contact | Tomoko Watanabe |
| Correspondent | Ryan Bouchard Ora, Inc. 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 | 2017-05-04 |
| Decision Date | 2018-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582273612822 | K171313 | 000 |
| 04582273603691 | K171313 | 000 |