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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer assisted hair harvesting system
510(k) Number K123548
Device Name THE ARTAS SYSTEM
Applicant
RESTORATION ROBOTICS, INC
128 BAYTECH DRIVE
SAN JOSE,  CA  95134
Applicant Contact JIM TALBOT
Correspondent
RESTORATION ROBOTICS, INC
128 BAYTECH DRIVE
SAN JOSE,  CA  95134
Correspondent Contact JIM TALBOT
Regulation Number882.4560
Classification Product Code
ONA  
Date Received11/19/2012
Decision Date 02/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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