| Device Classification Name |
Neurological Stereotaxic Instrument
|
| 510(k) Number |
K936019 |
| Device Name |
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS |
| Applicant |
| Nomos Corp. |
| 2593 Wexford Bayne Rd. |
| Suite 315 |
|
Sewickley,
PA
15143
|
|
| Applicant Contact |
MARVIN L SUSSMAN |
| Correspondent |
| Nomos Corp. |
| 2593 Wexford Bayne Rd. |
| Suite 315 |
|
Sewickley,
PA
15143
|
|
| Correspondent Contact |
MARVIN L SUSSMAN |
| Regulation Number | 882.4560 |
| Classification Product Code |
|
| Date Received | 12/17/1993 |
| Decision Date | 03/22/1994 |
| 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
|