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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 K001222
Device Name OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
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
Predetermined Change
Control Plan Authorized		 No
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