Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K141609 |
Device Name |
PULSTAR LOGIX PUMP |
Applicant |
ALBAHEALTH LLC |
425 N GATEWAY AVE. |
ROCKWOOD,
TN
37854
|
|
Applicant Contact |
SHANE BRUCE |
Correspondent |
ALBAHEALTH LLC |
425 N GATEWAY AVE. |
ROCKWOOD,
TN
37854
|
|
Correspondent Contact |
SHANE BRUCE |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 06/16/2014 |
Decision Date | 07/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|