Device Classification Name |
Filter, Infusion Line
|
510(k) Number |
K920736 |
Device Name |
IVEX-HP96 EXTENDED LIFE FILTER SET |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
FREDERICK A GUSTAFS |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
FREDERICK A GUSTAFS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/19/1992 |
Decision Date | 04/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|