| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K024084 |
| Device Name |
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 |
| Applicant |
| Abbott Laboratories |
| 200 Abbott Park Rd. |
|
Abbott Park,
IL
60064 -6157
|
|
| Applicant Contact |
FRANK POKROP |
| Correspondent |
| Abbott Laboratories |
| 200 Abbott Park Rd. |
|
Abbott Park,
IL
60064 -6157
|
|
| Correspondent Contact |
FRANK POKROP |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 12/11/2002 |
| Decision Date | 12/31/2002 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|