The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Sterile Surgical Pain Relief Electrode.
| Device ID | K830798 |
| 510k Number | K830798 |
| Device Name: | STERILE SURGICAL PAIN RELIEF ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | LECTEC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-14 |
| Decision Date | 1983-04-05 |