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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, Bldg. Ap30
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6157
Applicant Contact FRANK POKROP
Correspondent
Abbott Laboratories
Dept.37k, Bldg. Ap30
200 Abbott Park Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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