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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 K073672
Device Name SKATER BILIARY CATHETER
Applicant
Angiotech
13921 Park Center Rd.
Suite 100
Herndon,  VA  20171
Applicant Contact TRUDY ESTRIDGE
Correspondent
Angiotech
13921 Park Center Rd.
Suite 100
Herndon,  VA  20171
Correspondent Contact TRUDY ESTRIDGE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/27/2007
Decision Date 01/24/2008
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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