| Device Classification Name |
Display, Cathode-Ray Tube, Medical
|
| 510(k) Number |
K884423 |
| Device Name |
HORIZON DISPLAY CONTROLLER PART # 266-200-010 |
| Applicant |
| Mennen Medical, Inc. |
| 10123 Main St. |
|
Clarence,
NY
14031
|
|
| Applicant Contact |
THOMAS W CONNELLY |
| Correspondent |
| Mennen Medical, Inc. |
| 10123 Main St. |
|
Clarence,
NY
14031
|
|
| Correspondent Contact |
THOMAS W CONNELLY |
| Regulation Number | 870.2450 |
| Classification Product Code |
|
| Date Received | 10/19/1988 |
| Decision Date | 05/31/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|