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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 K941978
Device Name HIGH PRESSURE TUBING
Original Applicant
ABBOTT LABORATORIES
d-389, ap-30
200 abbott park road
abbott park,  IL  60064 3537
Original Contact frederik a gustafson
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/14/1994
Decision Date 12/13/1994
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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