Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K072666 |
Device Name |
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
Applicant |
BIO COMPRESSION SYSTEMS, INC. |
P.O. BOX 470218 |
BROADVIEW HEIGHTS,
OH
44141
|
|
Applicant Contact |
JAMES JOCHEN ROGERS |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/21/2007 |
Decision Date | 11/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|