| Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
| 510(k) Number |
K863723 |
| Device Name |
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT |
| Applicant |
| Norfolk Medical Products, Inc. |
| 7307 N. Ridgeway |
|
Skokie,
IL
60076
|
|
| Applicant Contact |
MICHAEL J DALTON |
| Correspondent |
| Norfolk Medical Products, Inc. |
| 7307 N. Ridgeway |
|
Skokie,
IL
60076
|
|
| Correspondent Contact |
MICHAEL J DALTON |
| Regulation Number | 880.5965 |
| Classification Product Code |
|
| Date Received | 09/23/1986 |
| Decision Date | 10/29/1986 |
| 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
|
|
|