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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 K000864
Device Name INTRASTENT DOUBLESTRUT XS STENT
Applicant
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact MARIA E BRITTLE
Correspondent
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/17/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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