Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K121950 |
Device Name |
MICROTARGETING XL STAR DRIVE SYSTEM |
Applicant |
FHC, INC. |
1201 MAIN ST |
BOWDOIN,
ME
04287
|
|
Applicant Contact |
KERI SEITZ |
Correspondent |
FHC, INC. |
1201 MAIN ST |
BOWDOIN,
ME
04287
|
|
Correspondent Contact |
KERI SEITZ |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 07/03/2012 |
Decision Date | 07/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|