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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
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 (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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