The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bicoag Coagulating Forceps.
Device ID | K971565 |
510k Number | K971565 |
Device Name: | BICOAG COAGULATING FORCEPS |
Classification | Coagulator-cutter, Endoscopic, Bipolar (and 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 | HIN |
CFR Regulation Number | 884.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-29 |
Decision Date | 1998-03-12 |
Summary: | summary |