The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Pf-400,gf-300,if-200,pg400,pg400c,and Ed-480.
| Device ID | K912112 |
| 510k Number | K912112 |
| Device Name: | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Carla Waggett |
| Correspondent | Carla Waggett TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | LQJ |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-06-17 |