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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 K991501
Device Name ACCLAIM INFUSION PUMP
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Applicant Contact JILL SACKETT
Correspondent
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064
Correspondent Contact JILL SACKETT
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/29/1999
Decision Date 05/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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