Device Classification Name |
Cover, Burr Hole
|
510(k) Number |
K123163 |
Device Name |
NEUROPACE BURR HOLE COVER MODEL 8110 |
Applicant |
NEUROPACE INC |
455 N. BERNARDO AVE |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
ISABELLA ABATI |
Correspondent |
NEUROPACE INC |
455 N. BERNARDO AVE |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
ISABELLA ABATI |
Regulation Number | 882.5250
|
Classification Product Code |
|
Date Received | 10/09/2012 |
Decision Date | 01/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|