| Device Classification Name |
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
|
| 510(k) Number |
K021102 |
| Device Name |
DM SLEEVE |
| Applicant |
| Emily Iker M.D., A.P.C. |
| 555 Thirteenth St. |
|
Washington,
DC
|
|
| Applicant Contact |
JONATHAN S KAHAN |
| Correspondent |
| Emily Iker M.D., A.P.C. |
| 555 Thirteenth St. |
|
Washington,
DC
|
|
| Correspondent Contact |
JONATHAN S KAHAN |
| Regulation Number | 880.5780 |
| Classification Product Code |
|
| Date Received | 04/04/2002 |
| Decision Date | 05/08/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|