| Device Classification Name |
Table, Physical Therapy, Multi Function
|
| 510(k) Number |
K930259 |
| Device Name |
TRACTION TABLE MODEL #825-200 |
| Applicant |
| Biodan Medical Systems, Ltd. |
| Brookhave R & D Plz. |
| 20 Ramsay Rd.,Box 702 |
|
Shirley,
NY
11967
|
|
| Applicant Contact |
CLYDE SCHLEIN |
| Correspondent |
| Biodan Medical Systems, Ltd. |
| Brookhave R & D Plz. |
| 20 Ramsay Rd.,Box 702 |
|
Shirley,
NY
11967
|
|
| Correspondent Contact |
CLYDE SCHLEIN |
| Regulation Number | 890.5880 |
| Classification Product Code |
|
| Date Received | 01/19/1993 |
| Decision Date | 03/24/1993 |
| 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
|
|
|