The following data is part of a premarket notification filed by Takagi Seiko Co., Ltd. with the FDA for Ellex Slit Lamp, Model 30xl.
| Device ID | K063352 |
| 510k Number | K063352 |
| Device Name: | ELLEX SLIT LAMP, MODEL 30XL |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TAKAGI SEIKO CO., LTD. 82 GILBERT STREET Adelaide, South Australia, AU 5000 |
| Contact | Kevin Howard |
| Correspondent | Kevin Howard TAKAGI SEIKO CO., LTD. 82 GILBERT STREET Adelaide, South Australia, AU 5000 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-03-13 |