The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bipolar Forceps.
Device ID | K912544 |
510k Number | K912544 |
Device Name: | BIPOLAR FORCEPS |
Classification | Syringe, Balloon Inflation |
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 | MAV |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-10 |
Decision Date | 1991-06-24 |