Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K011255 |
Device Name |
3D LINE STEROTACTIC HARDWARE ACCESSORIES |
Applicant |
3D LINE USA, INC. |
2807 OLD COURT RD. |
BALTIMORE,
MD
21208
|
|
Applicant Contact |
KAREN H RIGAMONTI |
Correspondent |
3D LINE USA, INC. |
2807 OLD COURT RD. |
BALTIMORE,
MD
21208
|
|
Correspondent Contact |
KAREN H RIGAMONTI |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/24/2001 |
Decision Date | 12/20/2001 |
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
|
|
|