Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K142772 |
Device Name |
Phlebo Press DVT 603 |
Applicant |
Mego Afek AC Ltd. |
Kibbutz Afek |
Kibbutz Afek,
IL
3004200
|
|
Applicant Contact |
Aharon Cohen |
Correspondent |
Mego Afek AC Ltd. |
Kibbutz Afek |
Kibbutz Afek,
IL
3004200
|
|
Correspondent Contact |
Aharon Cohen |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/25/2014 |
Decision Date | 12/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|