| 510(k) Number |
K837028 |
| Device Name |
PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY |
| Applicant |
| Ohio Medical Instrument Co., Inc. |
| 3924 Virginia Ave. |
|
Cincinnati,
OH
45227
|
|
| Correspondent |
| Ohio Medical Instrument Co., Inc. |
| 3924 Virginia Ave. |
|
Cincinnati,
OH
45227
|
|
| Date Received | 12/10/1982 |
| Decision Date | 03/09/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|