| Device Classification Name |
Exerciser, Finger, Powered
|
| 510(k) Number |
K900581 |
| Device Name |
DANNIFLEX CPM 880(TM) |
| Applicant |
| Buckman Co., Inc. |
| 1000 Burnett Ave., Suite 450 |
|
Concord,
CA
94520
|
|
| Applicant Contact |
DAVID W SCHLERF |
| Correspondent |
| Buckman Co., Inc. |
| 1000 Burnett Ave., Suite 450 |
|
Concord,
CA
94520
|
|
| Correspondent Contact |
DAVID W SCHLERF |
| Regulation Number | 890.5410 |
| Classification Product Code |
|
| Date Received | 02/07/1990 |
| Decision Date | 02/20/1990 |
| 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
|
|
|