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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 K033576
Device Name LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
Original Applicant
ABBOTT LABORATORIES
dept. 389, bldg. j45-2n
200 abbott park road
abbott park,  IL  60064 6133
Original Contact patricia melerski
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/13/2003
Decision Date 12/04/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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