FDA 510(k) Application Details - K172036

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K172036
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant Medrobotics Corporation
475 Paramount Drive
Raynham, MA 02767 US
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Contact John D. Bonasera
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 07/05/2017
Decision Date 08/03/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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