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FDA 510(k) Application Details - K123154
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
ONA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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