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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 K990592
Device Name INTRASTENT II
Applicant
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact CATHY YOHNK
Correspondent
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact CATHY YOHNK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/24/1999
Decision Date 09/01/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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