The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Evershears(r) Scissors, Bilap(r) Probes, Bicoag(r) Forceps.
| Device ID | K945975 |
| 510k Number | K945975 |
| Device Name: | EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Contact | David J Parins |
| Correspondent | David J Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis, MN 55441 -5444 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1994-12-21 |