Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K121962 |
Device Name |
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B |
Applicant |
MEGO AFEK AC LTD |
KIBBUTZ AFEK |
AFEK,
IL
30042
|
|
Applicant Contact |
ALEX RAPEL |
Correspondent |
MEGO AFEK AC LTD |
KIBBUTZ AFEK |
AFEK,
IL
30042
|
|
Correspondent Contact |
ALEX RAPEL |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 10/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|