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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 K172036
Device Name Medrobotics Flex Robotic System
Applicant
Medrobotics Corporation
475 Paramount Drive
Raynham,  MA  02767
Applicant Contact John D. Bonasera
Correspondent
Medrobotics Corporation
475 Paramount Drive
Raynham,  MA  02767
Correspondent Contact John D. Bonasera
Regulation Number876.1500
Classification Product Code
FDF  
Date Received07/05/2017
Decision Date 08/03/2017
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
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