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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 K021729
Device Name MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Applicant
SULZER INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112 -3495
Applicant Contact MARIA E BRITTLE
Correspondent
SULZER INTRATHERAPEUTICS, INC.
651 CAMPUS DR.
ST. PAUL,  MN  55112 -3495
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/24/2002
Decision Date 06/21/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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