| 510(k) Number |
K870418 |
| Device Name |
MYA-1 AND MYT-1 MYELOGRAM TRAY |
| Applicant |
| North Coast Medi-Tek |
| 8603 E. Ave. |
|
Mentor,
OH
44060
|
|
| Applicant Contact |
THERESA SOKOLOWSKI |
| Correspondent |
| North Coast Medi-Tek |
| 8603 E. Ave. |
|
Mentor,
OH
44060
|
|
| Correspondent Contact |
THERESA SOKOLOWSKI |
| Date Received | 02/03/1987 |
| Decision Date | 03/17/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|