The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Ophtec Rust Ring Remover.
| Device ID | K834354 |
| 510k Number | K834354 |
| Device Name: | OPHTEC RUST RING REMOVER |
| Classification | Burr, Corneal, Battery-powered |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-03-19 |