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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
Applicant Contact SANTA SUNDELL
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054
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
Predetermined Change
Control Plan Authorized		 No
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