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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 K992123
Device Name SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one sciemd place
maple grove,  MN  55311 1566
Contact melanie raska
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/23/1999
Decision Date 08/23/1999
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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