Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-