The following data is part of a premarket notification filed by Neomed Corp. with the FDA for Electrosurgical Unit 3001-3009.
| Device ID | K781810 |
| 510k Number | K781810 |
| Device Name: | ELECTROSURGICAL UNIT 3001-3009 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-26 |
| Decision Date | 1978-12-20 |