| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K883078 |
| Device Name |
INSULIN SYRINGE |
| Applicant |
| Select Sources, Inc. |
| P.O. Box 25b01 |
|
Los Angeles,
CA
90025
|
|
| Applicant Contact |
ALLEN S FARSHI |
| Correspondent |
| Select Sources, Inc. |
| P.O. Box 25b01 |
|
Los Angeles,
CA
90025
|
|
| Correspondent Contact |
ALLEN S FARSHI |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 07/19/1988 |
| Decision Date | 10/31/1988 |
| 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
|
|
|