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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 -2807
Applicant Contact MARGARET ANDERSON
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
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
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