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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 K914277
Device Name WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY
Applicant
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact RUSSELL W OLSON
Correspondent
Schneider U.S. Stent Div.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact RUSSELL W OLSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/24/1991
Decision Date 11/29/1991
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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