Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
|
510(k) Number |
K832906 |
Device Name |
PORT-A-CATH IMPLANTABLE CATHETER SYS |
Applicant |
PHARMACIA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PHARMACIA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5965 |
Classification Product Code |
|
Date Received | 08/29/1983 |
Decision Date | 03/06/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|