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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 K911292
Device Name SCHNEIDER WALLSTENT(R)
Applicant
PFIZER HOSPITAL PRODUCTS GROUP, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Applicant Contact STEVE JWANOUSKOS
Correspondent
PFIZER HOSPITAL PRODUCTS GROUP, INC.
5905 NATHAN LN.
MINNEAPOLIS,  MN  55442
Correspondent Contact STEVE JWANOUSKOS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/25/1991
Decision Date 05/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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