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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 K942329
Device Name HAND CONTROLLED SYRINGE
Original Applicant
ABBOTT LABORATORIES
d-389, ap-30
200 abbott park road
abbott park,  IL  60064 -3537
Original Contact frederick a gustafson
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/16/1994
Decision Date 06/20/1994
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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