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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 K052114
Device Name BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
Applicant
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280
Applicant Contact DENNIS SALZMANN
Correspondent
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280
Correspondent Contact DENNIS SALZMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/04/2005
Decision Date 08/25/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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