Device Classification Name |
Pump, Infusion, Pca
|
510(k) Number |
K022203 |
Device Name |
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 |
Applicant |
ABBOTT LABORATORIES |
DEPT 0389 BLDG J-45 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -6133
|
|
Applicant Contact |
FRANK POKROP |
Correspondent |
ABBOTT LABORATORIES |
DEPT 0389 BLDG J-45 |
200 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -6133
|
|
Correspondent Contact |
FRANK POKROP |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/05/2002 |
Decision Date | 08/01/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|