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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 K982159
Device Name ABBOTT PLUM A+ INFUSION PUMP
Applicant
ABBOTT LABORATORIES
1401 SHERIDAN RD.
NORTH CHICAGO,  IL  60064 -4000
Applicant Contact DAVID T GUZEK
Correspondent
ABBOTT LABORATORIES
1401 SHERIDAN RD.
NORTH CHICAGO,  IL  60064 -4000
Correspondent Contact DAVID T GUZEK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/19/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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