| Device Classification Name |
Exerciser, Measuring
|
| 510(k) Number |
K890401 |
| Device Name |
GOLDEN MEAN MACHINE(TM) (CLASS 2) |
| Applicant |
| Bennett Ergonomic Labs, Inc. |
| 12305 62nd St. N., Suite B |
|
Largo,
FL
34643
|
|
| Applicant Contact |
JOHN F BENNETT |
| Correspondent |
| Bennett Ergonomic Labs, Inc. |
| 12305 62nd St. N., Suite B |
|
Largo,
FL
34643
|
|
| Correspondent Contact |
JOHN F BENNETT |
| Regulation Number | 890.5360 |
| Classification Product Code |
|
| Date Received | 01/24/1989 |
| Decision Date | 04/21/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|