Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K123308 |
Device Name |
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM |
Applicant |
ALBAHEALTH, L.L.C. |
425 NORTH GATEWAY AVE. |
ROCKWOOD,
TN
37854
|
|
Applicant Contact |
PATRICK FRANK |
Correspondent |
ALBAHEALTH, L.L.C. |
425 NORTH GATEWAY AVE. |
ROCKWOOD,
TN
37854
|
|
Correspondent Contact |
PATRICK FRANK |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 10/24/2012 |
Decision Date | 02/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|