| 510(k) Number |
K852501 |
| Device Name |
MYELOGRAM PROCEDURE TRAY |
| Applicant |
| Manan Manufacturing Co., Inc. |
| 8020 N. Central Park Ave. |
|
Skokie,
IL
60076
|
|
| Applicant Contact |
MANFOED MITTERMEIER |
| Correspondent |
| Manan Manufacturing Co., Inc. |
| 8020 N. Central Park Ave. |
|
Skokie,
IL
60076
|
|
| Correspondent Contact |
MANFOED MITTERMEIER |
| Date Received | 06/12/1985 |
| Decision Date | 07/11/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|