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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 K001224
Device Name RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Applicant Contact MARGARET ANDERSON
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
Correspondent Contact MARGARET ANDERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/17/2000
Decision Date 05/17/2000
Decision SE - With Limitations (SESU)
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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