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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 K914299
Device Name CARDIAC CATHERIZATION 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 Received09/25/1991
Decision Date 06/03/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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