| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K953343 |
| Device Name |
NEEDLELESS INJECTION SITE |
| Applicant |
| Medical Associates Network, Inc. |
| 10572 Mahoney Dr. |
|
Sunland,
CA
91040
|
|
| Applicant Contact |
ROBERT T MERRICK |
| Correspondent |
| Medical Associates Network, Inc. |
| 10572 Mahoney Dr. |
|
Sunland,
CA
91040
|
|
| Correspondent Contact |
ROBERT T MERRICK |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 07/12/1995 |
| Decision Date | 10/26/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|