| Device Classification Name |
Components, Wheelchair
|
| 510(k) Number |
K925980 |
| Device Name |
PM |
| Applicant |
| Pathfinder Intl. Corp. |
| 1813 NW 102nd Way |
|
Gainesville,
FL
32606
|
|
| Applicant Contact |
ROBERT J HIRKO |
| Correspondent |
| Pathfinder Intl. Corp. |
| 1813 NW 102nd Way |
|
Gainesville,
FL
32606
|
|
| Correspondent Contact |
ROBERT J HIRKO |
| Regulation Number | 890.3920 |
| Classification Product Code |
|
| Date Received | 11/25/1992 |
| 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
|
|
|