Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K913986 |
Device Name |
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM |
Applicant |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JO BREHM |
Correspondent |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JO BREHM |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/05/1991 |
Decision Date | 01/28/1992 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|