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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 K943143
Device Name BILIARY STENT
Applicant
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Applicant Contact BOB BLEY
Correspondent
MENLO CARE, INC.
1350 WILLOW RD.
MENLO PARK,  CA  94025 -1516
Correspondent Contact BOB BLEY
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/30/1994
Decision Date 02/28/1995
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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