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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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