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510(k) K173358

Device
ARTAS System
Applicant
Restoration Robotics, Inc.
510(k) number
K173358
Product code
ONA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-16
Date received
2017-10-25
Regulation
882.4560
Classification name
Computer Assisted Hair Harvesting System
Medical specialty
Neurology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Raymond Lee
Address
128 Baytech Dr. San Josev CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ONA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123548THE ARTAS SYSTEMRestoration Robotics, Inc.2013-02-25
K123154ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.2013-02-19
K103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.2011-04-04

Legacy Summary#

summary

FDA Review#

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