| Device Classification Name |
Sleeve, Limb, Compressible
|
| 510(k) Number |
K060091 |
| Device Name |
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES |
| Applicant |
| Alliance Medical Corp. |
| 10232 S. 51st St. |
|
Phoenix,
AZ
85044
|
|
| Applicant Contact |
MOIRA BARTON |
| Correspondent |
| Alliance Medical Corp. |
| 10232 S. 51st St. |
|
Phoenix,
AZ
85044
|
|
| Correspondent Contact |
MOIRA BARTON |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 01/12/2006 |
| Decision Date | 02/17/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|