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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 K993588
Device Name MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Applicant Contact SANTA SUNDELL
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054 -2807
Correspondent Contact SANTA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/22/1999
Decision Date 11/17/1999
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
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