| Device Classification Name |
Sleeve, Limb, Compressible
|
| 510(k) Number |
K112311 |
| Device Name |
ALP 501 RB PUMP SYSTEM |
| Applicant |
| Currie Medical Specialties, Inc. |
| 730 E. Los Angeles Ave. |
|
Monrovia,
CA
91016
|
|
| Applicant Contact |
BERNICE NAVARRO |
| Correspondent |
| Currie Medical Specialties, Inc. |
| 730 E. Los Angeles Ave. |
|
Monrovia,
CA
91016
|
|
| Correspondent Contact |
BERNICE NAVARRO |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 08/11/2011 |
| Decision Date | 09/01/2011 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|