Device Classification Name |
Electrode, Cortical
|
510(k) Number |
K082474 |
Device Name |
PMT SUBDURAL CORTICAL ELECTRODES |
Applicant |
PMT CORP. |
1500 PARK RD. |
CHANHASSEN,
MN
55317
|
|
Applicant Contact |
ERIC CAILLE |
Correspondent |
PMT CORP. |
1500 PARK RD. |
CHANHASSEN,
MN
55317
|
|
Correspondent Contact |
ERIC CAILLE |
Regulation Number | 882.1310
|
Classification Product Code |
|
Date Received | 08/28/2008 |
Decision Date | 05/08/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|