The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Evershears Scissors, Bilap Probes, Bicoag Forceps.
Device ID | K955001 |
510k Number | K955001 |
Device Name: | EVERSHEARS SCISSORS, BILAP PROBES, BICOAG 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 | 1995-11-02 |
Decision Date | 1995-12-13 |