The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Laparoscopic Electrosurgical Device.
| Device ID | K904993 |
| 510k Number | K904993 |
| Device Name: | LAPAROSCOPIC ELECTROSURGICAL DEVICE |
| 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 | 1990-11-07 |
| Decision Date | 1991-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036013857 | K904993 | 000 |
| 30705036011891 | K904993 | 000 |
| 30705036011884 | K904993 | 000 |
| 30705036004022 | K904993 | 000 |
| 00821925009677 | K904993 | 000 |