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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, biliary, diagnostic
510(k) Number K122546
Device Name SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Original Applicant
IDEV TECHNOLOGIES, INC.
253 medical center blvd.
webster,  TX  77598
Original Contact darlene garner
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/21/2012
Decision Date 12/07/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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