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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K024126
Device Name CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Original Applicant
ABBOTT LABORATORIES
200 abbott park rd.
d-389, bldg j-45
abbott park,  IL  60064 3500
Original Contact nicohl r wilding
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/16/2002
Decision Date 01/14/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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