| Device Classification Name |
retractor, self-retaining, for neurosurgery
|
|---|
| 510(k) Number |
K150378 |
|---|
| Device Name |
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook |
|---|
| Applicant |
| NICO Corporation |
| 250 E 96TH ST Suite 125 |
|
Indianapolis,
IN
46240
|
|
| Applicant Contact |
Sean Spence |
| Correspondent |
| NICO Corporation |
| 250 E 96TH ST Suite 125 |
|
Indianapolis,
IN
46240
|
|
| Correspondent Contact |
Sean Spence |
| Regulation Number | 882.4800
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/13/2015 |
|---|
| Decision Date | 06/12/2015 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|