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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 K905714
Device Name ERCP CANNULA
Applicant
EVEREST MEDICAL CORP.
13755 FIRST AVENUE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact DAVID PARINS
Correspondent
EVEREST MEDICAL CORP.
13755 FIRST AVENUE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact DAVID PARINS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/21/1990
Decision Date 02/01/1991
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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