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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 K011442
Device Name ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
Applicant
ABBOTT LABORATORIES
DEPT 37K BLDG AP30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064
Applicant Contact FRANK POKROP
Correspondent
ABBOTT LABORATORIES
DEPT 37K BLDG AP30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064
Correspondent Contact FRANK POKROP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/10/2001
Decision Date 06/05/2001
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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