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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 K924387
Device Name INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
Applicant
Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact WARREN BIELKE
Correspondent
Instent, Inc.
6271 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact WARREN BIELKE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/31/1992
Decision Date 09/08/1995
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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