The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bipolar Biopsy Forceps.
Device ID | K904985 |
510k Number | K904985 |
Device Name: | BIPOLAR BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Electric |
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 | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-02 |
Decision Date | 1991-01-25 |