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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 K980290
Device Name ITI STENT
Applicant
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact AMY PETERSON
Correspondent
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact AMY PETERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/26/1998
Decision Date 07/21/1998
Decision Substantially Equivalent (SESE)
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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