The following data is part of a premarket notification filed by Merced Medical, Inc. with the FDA for Ley Electro-surgical Units.
| Device ID | K790642 |
| 510k Number | K790642 |
| Device Name: | LEY ELECTRO-SURGICAL UNITS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MERCED MEDICAL, INC. 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 | 1979-03-30 |
| Decision Date | 1979-05-08 |