| Device Classification Name |
Component, Cast
|
| 510(k) Number |
K861075 |
| Device Name |
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202 |
| Applicant |
| Martin Medical |
| 36270 W. 103rd St. |
| P.O. Box 590 |
|
Desoto,
KS
66018
|
|
| Applicant Contact |
RANDY S KILBURN |
| Correspondent |
| Martin Medical |
| 36270 W. 103rd St. |
| P.O. Box 590 |
|
Desoto,
KS
66018
|
|
| Correspondent Contact |
RANDY S KILBURN |
| Regulation Number | 888.5940 |
| Classification Product Code |
|
| Date Received | 03/21/1986 |
| Decision Date | 03/28/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|