FDA 510(k) Application Details - K123154

Device Classification Name

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510(K) Number K123154
Device Name ARTAS SYSTEM FROM RESTORATION ROBOTICS
Applicant RESTORATION ROBOTICS, INC
128 BAYTECH DRIVE
SAN JOSE, CA 95134 US
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Contact JIM TALBOT
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Regulation Number

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Classification Product Code ONA
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Date Received 10/09/2012
Decision Date 02/19/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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