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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 K030002
Device Name LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
Original Applicant
ABBOTT LABORATORIES
d-389, bldg. j45-2
200 abbott park road
abbott park,  IL  60064 6157
Original Contact nocohl r wilding
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/02/2003
Decision Date 01/27/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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