| Device Classification Name |
cover, burr hole
|
|---|
| 510(k) Number |
K141368 |
|---|
| Device Name |
NEUROPACE BURR HOLE COVER |
|---|
| Applicant |
| NEUROPACE INC |
| 455 N. BERNARDO AVE |
|
MOUNTAIN VIEW,
CA
94043
|
|
| Applicant Contact |
ISABELLA R ABATI |
| Correspondent |
| NEUROPACE INC |
| 455 N. BERNARDO AVE |
|
MOUNTAIN VIEW,
CA
94043
|
|
| Correspondent Contact |
ISABELLA R ABATI |
| Regulation Number | 882.5250
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/23/2014 |
|---|
| Decision Date | 07/11/2014 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Summary |
Summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|