Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K052851 |
Device Name |
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) |
Applicant |
MAKO SURGICAL CORP. |
2901 SIMMS STREET |
HOLLYWOOD,
FL
33020
|
|
Applicant Contact |
WILLIAM F TAPIA |
Correspondent |
MAKO SURGICAL CORP. |
2901 SIMMS STREET |
HOLLYWOOD,
FL
33020
|
|
Correspondent Contact |
WILLIAM F TAPIA |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 10/11/2005 |
Decision Date | 11/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|