Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K131327 |
Device Name |
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
Applicant |
BIO COMPRESSION SYSTEMS, INC. |
1983 HAZELWOOD ROAD |
TOMS RIVER,
NJ
08753
|
|
Applicant Contact |
Maureen Garner |
Correspondent |
BIO COMPRESSION SYSTEMS, INC. |
1983 HAZELWOOD ROAD |
TOMS RIVER,
NJ
08753
|
|
Correspondent Contact |
Maureen Garner |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/08/2013 |
Decision Date | 07/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|