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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 K122878
Device Name HD-IVUS ULTRASOUND IMAGING SYSTEM
Applicant
SILICON VALLY MEDICAL INSTRUMENTS, INC.
47697 westinghouse
suite 101
fremont,  CA  94539
Contact richard e anderson
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received09/26/2012
Decision Date 01/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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