The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Tomey Em-1000 Specular Microscope.
| Device ID | K944910 |
| 510k Number | K944910 |
| Device Name: | TOMEY EM-1000 SPECULAR MICROSCOPE |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TOMEY CORPORATION USA 15825 SHADY GROVE ROAD SUITE 30 Rockville, MD 20850 |
| Contact | Richard E Lippman, O.d. F.a.a.o. |
| Correspondent | Richard E Lippman, O.d. F.a.a.o. TOMEY CORPORATION USA 15825 SHADY GROVE ROAD SUITE 30 Rockville, MD 20850 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-05 |
| Decision Date | 1994-11-22 |
| Summary: | summary |