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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 K011217
Device Name CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
Original Applicant
ABBOTT LABORATORIES
dept. 389, ap30
200 abbott park rd.
abbott park,  IL  60064 -3537
Original Contact thomas p sampogna
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/20/2001
Decision Date 05/16/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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