Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K113525 |
Device Name |
ACTIVECARE DVT ACTIVECARE+SFT |
Applicant |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
117 AHUZAH ST. |
RA'ANANNA 43373,
IL
43373
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
117 AHUZAH ST. |
RA'ANANNA 43373,
IL
43373
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/29/2011 |
Decision Date | 01/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|