Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K060220 |
Device Name |
PBS MODEL 701A COMPRESSION THERAPY DEVICE |
Applicant |
MEGO AFEK |
BEIT HAPA'AMON (BOX 124) |
20 HATA'AS ST., |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA M STEIN |
Correspondent |
MEGO AFEK |
BEIT HAPA'AMON (BOX 124) |
20 HATA'AS ST., |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA M STEIN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 01/30/2006 |
Decision Date | 02/09/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|