Device Classification Name |
pump, infusion
|
510(k) Number |
K912928 |
Device Name |
LIFECARE 4100 PCA INFUSER PLUS II |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
FREDERICK GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
FREDERICK GUSTAFSON |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/05/1991 |
Decision Date | 08/26/1991 |
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
|
|
|