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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 K111766
Device Name SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
Applicant
IDEV TECHNOLOGIES, INC.
253 MEDICAL CENTER BLVD
WEBSTER,  TX  77598
Applicant Contact DARENE GARNER
Correspondent
IDEV TECHNOLOGIES, INC.
253 MEDICAL CENTER BLVD
WEBSTER,  TX  77598
Correspondent Contact DARENE GARNER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/23/2011
Decision Date 10/19/2011
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
Recalls CDRH Recalls
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