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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K934513
Device Name PROVIDER PUMP SET W/INFUSION CARTRIDGE
Original Applicant
ABBOTT LABORATORIES
one abbott park rd.
d389, ap30
abbott park,  IL  60064
Original Contact frederick a gustafson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/15/1993
Decision Date 07/29/1994
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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