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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 K030638
Device Name DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
Applicant
AVANTEC VASCULAR CORP.
1049 KIEL CT.
SUNNYVALE,  CA  94089
Applicant Contact JAMES M SHY
Correspondent
AVANTEC VASCULAR CORP.
1049 KIEL CT.
SUNNYVALE,  CA  94089
Correspondent Contact JAMES M SHY
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/28/2003
Decision Date 07/09/2003
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
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