The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Confoscan.
| Device ID | K971953 |
| 510k Number | K971953 |
| Device Name: | CONFOSCAN |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Dave Maclellan |
| Correspondent | Dave Maclellan TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1997-08-14 |
| Summary: | summary |