Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K091700 |
Device Name |
AIRCAST VENAFLOW ELITE SYSTEM |
Applicant |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Applicant Contact |
CHRISTINE OTIS |
Correspondent |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Correspondent Contact |
CHRISTINE OTIS |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 06/10/2009 |
Decision Date | 07/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|