The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Tomey Dtl Electrode.
| Device ID | K961805 |
| 510k Number | K961805 |
| Device Name: | TOMEY DTL ELECTRODE |
| Classification | Electrode, Corneal |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Susumu Nozawa |
| Correspondent | Susumu Nozawa TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | HLZ |
| CFR Regulation Number | 886.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1997-05-09 |
| Summary: | summary |