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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K141598
Device Name FUSE COLONOSCOPY SYSTEM
Applicant
ENDOCHOICE, INC.
3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH)
CAESAREA,  IL 3088900
Applicant Contact TAMAR FUERST
Correspondent
ENDOCHOICE, INC.
3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH)
CAESAREA,  IL 3088900
Correspondent Contact TAMAR FUERST
Regulation Number876.1500
Classification Product Code
FDF  
Date Received06/13/2014
Decision Date 09/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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