| Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
| 510(k) Number |
K840355 |
| Device Name |
DESERET MULTILUMEN SUBCLAVIAN JUGULAR |
| Applicant |
| Parke-Davis Co. |
| 2337 Parkdale Ave. |
|
Brookville, Ontario,
CA
K62 5WS
|
|
| Correspondent |
| Parke-Davis Co. |
| 2337 Parkdale Ave. |
|
Brookville, Ontario,
CA
K62 5WS
|
|
| Regulation Number | 880.5200 |
| Classification Product Code |
|
| Date Received | 01/26/1984 |
| Decision Date | 03/19/1984 |
| 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
|
|
|