Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K092562 |
Device Name |
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS |
Applicant |
FHC, INC. |
1201 MAIN ST |
BOWDOIN,
ME
04287
|
|
Applicant Contact |
LEE D MARGOLIN |
Correspondent |
FHC, INC. |
1201 MAIN ST |
BOWDOIN,
ME
04287
|
|
Correspondent Contact |
LEE D MARGOLIN |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/20/2009 |
Decision Date | 09/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|