Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K981684 |
Device Name |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
Applicant |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
530 COMPTON ST. |
BROOMFIELD,
CO
80020
|
|
Applicant Contact |
ROGER N WHITE |
Correspondent |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
530 COMPTON ST. |
BROOMFIELD,
CO
80020
|
|
Correspondent Contact |
ROGER N WHITE |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 05/13/1998 |
Decision Date | 08/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|