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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 K965230
Device Name ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
Applicant
ABBOTT MFG., INC.
ONE ABBOTT PARK
ABBOTT PARK,  IL  60064
Applicant Contact DAVID GUZEK
Correspondent
ABBOTT MFG., INC.
ONE ABBOTT PARK
ABBOTT PARK,  IL  60064
Correspondent Contact DAVID GUZEK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/31/1996
Decision Date 07/03/1997
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
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