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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 K000743
Device Name BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove,  MN  55311 1566
Original Contact deborah a frank
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/07/2000
Decision Date 09/06/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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