Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K083576 |
Device Name |
MISER CONTRAST MANAGEMENT SYSTEM |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
STEPHANIE ERSKINE |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
STEPHANIE ERSKINE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/03/2008 |
Decision Date | 12/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|