Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K001712 |
Device Name |
3D ACTIVETRAC |
Applicant |
THE SAUNDERS GROUP |
4250 NOREX DR. |
CHASKA,
MN
55318 -3047
|
|
Applicant Contact |
DOUGLAS G TOMASKO |
Correspondent |
THE SAUNDERS GROUP |
4250 NOREX DR. |
CHASKA,
MN
55318 -3047
|
|
Correspondent Contact |
DOUGLAS G TOMASKO |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 06/05/2000 |
Decision Date | 08/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|