| Device Classification Name |
Device, Peritoneal Access, Subcutaneous, Implanted
|
| 510(k) Number |
K854593 |
| Device Name |
NORFOLK MEDICAL PERITONEAL-ACCESS PORT |
| 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 |
| Classification Product Code |
|
| Date Received | 11/18/1985 |
| Decision Date | 02/04/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|