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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 K072720
Device Name ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
Applicant
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Applicant Contact TONY D ALEXANDER
Correspondent
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Correspondent Contact TONY D ALEXANDER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/25/2007
Decision Date 04/11/2008
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
Recalls CDRH Recalls
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