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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 K121832
Model RBC-X-038 & RBDC-X-038
Device Name RESOLVE BILIARY LOCKING DRAINAGE CATHETER
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 south velasco st
angleton,  TX  77515
Original Contact casey hughes
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/22/2012
Decision Date 07/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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