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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K122546
Device Name SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Applicant
IDEV TECHNOLOGIES, INC.
253 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact DARLENE GARNER
Correspondent
IDEV TECHNOLOGIES, INC.
253 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact DARLENE GARNER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/21/2012
Decision Date 12/07/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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