Device Classification Name |
catheter, cholangiography
|
510(k) Number |
K925742 |
Device Name |
CLARUS CHOLANGIOGRAM CATHETER KIT |
Applicant |
CLARUS MEDICAL SYSTEMS, INC. |
2605 FERNBROOK LA |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
GREGORY J MATHISON |
Correspondent |
CLARUS MEDICAL SYSTEMS, INC. |
2605 FERNBROOK LA |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
GREGORY J MATHISON |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 11/13/1992 |
Decision Date | 06/01/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|