Device Classification Name |
filter, infusion line
|
510(k) Number |
K941684 |
Device Name |
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
D389, AP30 |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
FREDERICK A GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
D389, AP30 |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
FREDERICK A GUSTAFSON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/04/1994 |
Decision Date | 08/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|