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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 K003997
Device Name INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
Applicant
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Applicant Contact AMY PETERSON
Correspondent
INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112
Correspondent Contact AMY PETERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/26/2000
Decision Date 01/24/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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