Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K100038 |
Device Name |
DISPOSABLE REFLECTIVE MARKER SPHERES |
Applicant |
BRAINLAB, AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Applicant Contact |
ALEXANDER SCHWIERSCH |
Correspondent |
BRAINLAB, AG |
KAPELLENSTRASSE 12 |
FELDKIRCHEN,
DE
85622
|
|
Correspondent Contact |
ALEXANDER SCHWIERSCH |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/07/2010 |
Decision Date | 07/14/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|