Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K060146 |
Device Name |
ACTIVECARE ++ SYSTEM |
Applicant |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
7 JABOTINSKY STREET |
MOSHE AVIV TOWER |
RAMAT GAN,
IL
52520
|
|
Applicant Contact |
DORIT WINITZ |
Correspondent |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
7 JABOTINSKY STREET |
MOSHE AVIV TOWER |
RAMAT GAN,
IL
52520
|
|
Correspondent Contact |
DORIT WINITZ |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 01/19/2006 |
Decision Date | 03/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|