The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Erg-jet Electrode.
| Device ID | K823767 |
| 510k Number | K823767 |
| Device Name: | ERG-JET ELECTRODE |
| Classification | Device, Measuring, Lens Radius, Ophthalmic |
| Applicant | LIFE-TECH INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLF |
| CFR Regulation Number | 886.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-01-08 |