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 Number | 882.4560
|
Classification Product Code |
|
Date Received | 11/22/2010 |
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
|