| Device Classification Name |
Clip, Scalp
|
| 510(k) Number |
K896723 |
| Device Name |
CLIP GUN WITH RANEY TYPE SCALP CLIPS |
| Applicant |
| Omni Medical Designs |
| 19500 Middlebelt, Suite 333e |
|
Livonia,
MI
48152
|
|
| Applicant Contact |
ALAN TASH |
| Correspondent |
| Omni Medical Designs |
| 19500 Middlebelt, Suite 333e |
|
Livonia,
MI
48152
|
|
| Correspondent Contact |
ALAN TASH |
| Regulation Number | 882.4150 |
| Classification Product Code |
|
| Date Received | 11/29/1989 |
| Decision Date | 03/23/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|