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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K172796
Device Name Flex Robotic System and Flex Transabdominal Drive
Applicant
MEDROBOTICS CORPORATION
475 Paramount Drive
Raynham,  MA  02767
Applicant Contact Linda J Varroso
Correspondent
MEDROBOTICS CORPORATION
475 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Linda J Varroso
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
GCJ  
Date Received09/15/2017
Decision Date 01/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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