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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 K955126
Device Name LMI BILIARY CATHETER
Applicant
LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM,  CA  92806
Applicant Contact DANIEL R LUCAS
Correspondent
LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM,  CA  92806
Correspondent Contact DANIEL R LUCAS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/09/1995
Decision Date 05/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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