Device Classification Name |
pump, infusion
|
510(k) Number |
K023062 |
Device Name |
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT |
Applicant |
ABBOTT LABORATORIES INC |
200 ABBOTT PARK RD. |
DEPT 0389 BLDG J-45 |
ABBOTT PARK,
IL
60064 -6133
|
|
Applicant Contact |
FRANK POKROP |
Correspondent |
ABBOTT LABORATORIES INC |
200 ABBOTT PARK RD. |
DEPT 0389 BLDG J-45 |
ABBOTT PARK,
IL
60064 -6133
|
|
Correspondent Contact |
FRANK POKROP |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/16/2002 |
Decision Date | 09/30/2002 |
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
|
|
|