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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 K896163
Device Name SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
Applicant
Schneider Stent
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact ALAN MARQUARDT
Correspondent
Schneider Stent
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact ALAN MARQUARDT
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/24/1989
Decision Date 12/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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