Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K122499 |
Device Name |
AIRCAST VENAFLOW ELITE SYSTEM |
Applicant |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Applicant Contact |
KEN FISHER |
Correspondent |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Correspondent Contact |
KEN FISHER |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 10/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|