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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 K932141
Device Name CARDIAC CATHETERIZATION KIT
Original Applicant
ABBOTT LABORATORIES
one abbott park rd.
abbott park,  IL  60064 3500
Original Contact frederick gustafson
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/22/1993
Decision Date 09/22/1994
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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