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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 K945498
Device Name INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
Applicant
INSTENT, INC.
6271 BURY DR.
EDEN PRAIRIE,  MN  55346
Applicant Contact KARL GROTH
Correspondent
INSTENT, INC.
6271 BURY DR.
EDEN PRAIRIE,  MN  55346
Correspondent Contact KARL GROTH
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/08/1994
Decision Date 09/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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