Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K053316 |
Device Name |
REPROCESSED COMPRESSION SLEEVES |
Applicant |
ALLIANCE MEDICAL CORP. |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
MOIRA BARTON |
Correspondent |
ALLIANCE MEDICAL CORP. |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
MOIRA BARTON |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 11/29/2005 |
Decision Date | 02/13/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|