The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Cholangiography/cholangioscopy/lihopaxy System.
| Device ID | K913986 |
| 510k Number | K913986 |
| Device Name: | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1992-01-28 |