Device Classification Name |
Pump, Infusion
|
510(k) Number |
K982159 |
Device Name |
ABBOTT PLUM A+ INFUSION PUMP |
Applicant |
ABBOTT LABORATORIES |
1401 SHERIDAN RD. |
NORTH CHICAGO,
IL
60064 -4000
|
|
Applicant Contact |
DAVID T GUZEK |
Correspondent |
ABBOTT LABORATORIES |
1401 SHERIDAN RD. |
NORTH CHICAGO,
IL
60064 -4000
|
|
Correspondent Contact |
DAVID T GUZEK |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/19/1998 |
Decision Date | 01/12/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|