| Device Classification Name |
Set, Administration, Intravascular
|
| 510(k) Number |
K854804 |
| Device Name |
MULTIPLE I.V. SETS |
| Applicant |
| C. B. Dumont Company, Inc. |
| P.O. Box 418 |
|
Newport,
RI
02840
|
|
| Applicant Contact |
BERTRAND DUMONT |
| Correspondent |
| C. B. Dumont Company, Inc. |
| P.O. Box 418 |
|
Newport,
RI
02840
|
|
| Correspondent Contact |
BERTRAND DUMONT |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 12/02/1985 |
| Decision Date | 02/12/1986 |
| 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
|
|
|