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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 K923993
Device Name WALLSTENT BILIARY ENDOPROTHESES
Applicant
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact AMY PETERSON
Correspondent
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact AMY PETERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/10/1992
Decision Date 09/30/1994
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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