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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 K071646
Device Name SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
Applicant
Idev Technologies, Inc.
1120 Nasa Pkwy., Suite 600
Houston,  TX  77058
Applicant Contact TIMOTHY R PLACEK
Correspondent
Idev Technologies, Inc.
1120 Nasa Pkwy., Suite 600
Houston,  TX  77058
Correspondent Contact TIMOTHY R PLACEK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/18/2007
Decision Date 01/31/2008
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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