Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K112677 |
Device Name |
THE VENOUS ASSIST SYSTEM |
Applicant |
DAESUNG MAREF CO., LTD. |
4568 WEST 1ST STREET |
SUITE 104 |
LOS ANGELES,
CA
90004
|
|
Applicant Contact |
DANIEL NAM |
Correspondent |
DAESUNG MAREF CO., LTD. |
4568 WEST 1ST STREET |
SUITE 104 |
LOS ANGELES,
CA
90004
|
|
Correspondent Contact |
DANIEL NAM |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/14/2011 |
Decision Date | 01/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|