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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 K992319
Device Name RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Applicant Contact SANDRA SUNDELL
Correspondent
GUIDANT CORP.
3200 LAKESIDE DR.
P.O. BOX 58167
SANTA CLARA,  CA  95052 -8167
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/12/1999
Decision Date 10/08/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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