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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 K010924
Device Name MODIFICATION TO PLUM XL INFUSION PUMP
Applicant
ABBOTT LABORATORIES
DEPT.37K, BUILDING AP30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Applicant Contact FRANK POKROP
Correspondent
ABBOTT LABORATORIES
DEPT.37K, BUILDING AP30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Correspondent Contact FRANK POKROP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/27/2001
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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