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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 K844384
Device Name BILIARY STENT PROSTHESIS
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact CHRISTINE EMANUEL
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact CHRISTINE EMANUEL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/13/1984
Decision Date 02/14/1985
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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