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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 K023666
Device Name RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
Applicant
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Applicant Contact RICK LYKINS
Correspondent
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Correspondent Contact RICK LYKINS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/31/2002
Decision Date 06/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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