| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K950304 |
| Device Name |
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER |
| Applicant |
| Becton Dickinson Vascular Access, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Applicant Contact |
C. J WELLE |
| Correspondent |
| Becton Dickinson Vascular Access, Inc. |
| 9450 S. State St. |
|
Sandy,
UT
84070
|
|
| Correspondent Contact |
C. J WELLE |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 01/25/1995 |
| Decision Date | 03/14/1995 |
| 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
|
|
|