Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K011992 |
Device Name |
FHC MICROTARGETING DRIVE SYSTEM |
Applicant |
FHC, INC. |
9 MAIN ST. |
BOWDOINHAM,
ME
04008
|
|
Applicant Contact |
FREDERICK HAER |
Correspondent |
FHC, INC. |
9 MAIN ST. |
BOWDOINHAM,
ME
04008
|
|
Correspondent Contact |
FREDERICK HAER |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 06/26/2001 |
Decision Date | 08/14/2001 |
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
|
|
|