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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K161147
Device Name EndoCure Model EUR078A
Applicant
ENDOCURE TECHNOLOGIES, INC.
5801 AMMENDALE ROAD, SUITE A
BELTSVILLE,  MD  20705
Applicant Contact CHARLES J. NEFF
Correspondent
SMITH ASSOCIATES
1468 HARWELL AVENUE
CROFTON,  MD  21114
Correspondent Contact E.J. SMITH
Regulation Number876.1500
Classification Product Code
FBN  
Date Received04/22/2016
Decision Date 06/07/2016
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
Predetermined Change
Control Plan Authorized		 No
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