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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 K103428
Device Name THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
Applicant
RESTORATION ROBOTICS, INC
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
RESTORATION ROBOTICS, INC
155-A MOFFETT PARK DRIVE
SUITE 210
SUNNYVALE,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number882.4560
Classification Product Code
ONA  
Date Received11/22/2010
Decision Date 04/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00926211
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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