| 510(k) Number |
K864501 |
| Device Name |
KOKEN'S NEW MODEL M-3000 POWER TABLE |
| Applicant |
| Koken Mfg Company, Inc. |
| P.O. Box 265 |
|
St. Louis,
MO
63166
|
|
| Applicant Contact |
MASAYA KOSAKA |
| Correspondent |
| Koken Mfg Company, Inc. |
| P.O. Box 265 |
|
St. Louis,
MO
63166
|
|
| Correspondent Contact |
MASAYA KOSAKA |
| Date Received | 11/14/1986 |
| Decision Date | 12/16/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|