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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 K173358
Device Name ARTAS System
Applicant
Restoration Robotics, Inc.
128 Baytech Drive
San Jose,  CA  95134
Applicant Contact Raymond Lee
Correspondent
Restoration Robotics, Inc.
128 Baytech Drive
San Jose,  CA  95134
Correspondent Contact Raymond Lee
Regulation Number882.4560
Classification Product Code
ONA  
Date Received10/25/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02914587
Reviewed by Third Party No
Combination Product No
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