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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 K925406
Device Name BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
Applicant
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact AMY PETERSON
Correspondent
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact AMY PETERSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/26/1992
Decision Date 01/11/1995
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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