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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 K000550
Device Name OTW MEGALINK SDS BILIARY STENT SYSTEM
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052 -8167
Applicant Contact SANDRA SUNDELL
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052 -8167
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/18/2000
Decision Date 03/17/2000
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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