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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 K941254
Device Name DYE MANAGEMENT SYSTEM
Original Applicant
ABBOTT LABORATORIES
one abbott park rd.
d389, ap30
abbott park,  IL  60064
Original Contact frederick a gustafson
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/11/1994
Decision Date 06/13/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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