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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number880.5725
Classification Product Code
FRN  
Date Received09/16/2002
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
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