The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Laparoscopic Electrosurg Device W/irriga & Aspira.
| Device ID | K922509 |
| 510k Number | K922509 |
| Device Name: | LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Contact | David J Parins |
| Correspondent | David J Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-10-01 |