The following data is part of a premarket notification filed by Universo S.a. with the FDA for Erg-jet Electrode.
| Device ID | K830557 |
| 510k Number | K830557 |
| Device Name: | ERG-JET ELECTRODE |
| Classification | Electrode, Corneal |
| Applicant | UNIVERSO S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HLZ |
| CFR Regulation Number | 886.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-03-31 |