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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 K853666
Device Name ENDODYNAMICS SIEGEL THERAPUTIC STENT
Applicant
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Applicant Contact JACK T BERGER
Correspondent
E-Z-EM, INC.
717 MAIN ST.
WESTBURY,  NY  11590
Correspondent Contact JACK T BERGER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/03/1985
Decision Date 11/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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