Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K954283 |
Device Name |
ENERGIZED CONTAINER SYSTEM (MODIFICATION) |
Applicant |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3537
|
|
Applicant Contact |
DAVID T GUZEK |
Correspondent |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3537
|
|
Correspondent Contact |
DAVID T GUZEK |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/05/1995 |
Decision Date | 05/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|