| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K874807 |
| Device Name |
EXTRAVAKIT |
| Applicant |
| Cancer Technologies, Inc. |
| P.O. Box 12865 |
|
Tucson,
AZ
85732
|
|
| Applicant Contact |
DORR, PHD |
| Correspondent |
| Cancer Technologies, Inc. |
| P.O. Box 12865 |
|
Tucson,
AZ
85732
|
|
| Correspondent Contact |
DORR, PHD |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 11/20/1987 |
| Decision Date | 02/04/1988 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 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
|
|
|