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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 K023243
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 Received09/30/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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