The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Ercp Cannula.
| Device ID | K905714 |
| 510k Number | K905714 |
| Device Name: | ERCP CANNULA |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Contact | David Parins |
| Correspondent | David Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-21 |
| Decision Date | 1991-02-01 |