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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromechanical system for open microsurgery
Definition An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
Product CodeSAQ
Regulation Number 878.4963
Device Class 2


Premarket Reviews
ManufacturerDecision
MMI NORTH AMERICA, INC.
  GRANTED 1

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