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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 K924107
Device Name ERCP CANNULA
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Applicant Contact MARLIN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Correspondent Contact MARLIN YOUNKER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/13/1992
Decision Date 12/30/1992
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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