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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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