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
|
|
|