Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K954276 |
Device Name |
STEALTHSTATION |
Applicant |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
530 COMPTON ST. |
BROOMFIELD,
CO
80020
|
|
Applicant Contact |
KURT R SMITH |
Correspondent |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
530 COMPTON ST. |
BROOMFIELD,
CO
80020
|
|
Correspondent Contact |
KURT R SMITH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 09/13/1995 |
Decision Date | 01/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|