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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ultrasound, intravascular
510(k) Number K113008
Model TBD
Device Name KODAMA INTRAVASCULAR ULRASOUND CATHETER
Original Applicant
SILICON VALLY MEDICAL INSTRUMENTS, INC.
47697 westinghouse
suite 101
fremont,  CA  94539
Original Contact richard e anderson
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received10/07/2011
Decision Date 06/14/2012
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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