| Device Classification Name |
Sleeve, Limb, Compressible
|
| 510(k) Number |
K895732 |
| Device Name |
JOBST ATHROMBIC PUMP(R) SYSTEM 2000 |
| Applicant |
| Jobst Institute, Inc. |
| P.O. Box 653 |
|
Toledo,
OH
43697
|
|
| Applicant Contact |
WETZEL, CM |
| Correspondent |
| Jobst Institute, Inc. |
| P.O. Box 653 |
|
Toledo,
OH
43697
|
|
| Correspondent Contact |
WETZEL, CM |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 09/26/1989 |
| Decision Date | 01/26/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|