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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 K021350
Device Name ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
Applicant
ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Applicant Contact FRANK POKROP
Correspondent
ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Correspondent Contact FRANK POKROP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/29/2002
Decision Date 05/14/2002
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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