| Device Classification Name |
Container, I.V.
|
| 510(k) Number |
K841597 |
| Device Name |
GIL-MED PARENTERAL NUTRITION OR MEDICINE |
| Applicant |
| Gil-Med Industries C/O Kegan & Kegan, Ltd. |
| 79 W. Monroe St., Suite 1320 |
|
Chicago,
IL
60603
|
|
| Applicant Contact |
O KEGAN |
| Correspondent |
| Gil-Med Industries C/O Kegan & Kegan, Ltd. |
| 79 W. Monroe St., Suite 1320 |
|
Chicago,
IL
60603
|
|
| Correspondent Contact |
O KEGAN |
| Regulation Number | 880.5025 |
| Classification Product Code |
|
| Date Received | 04/18/1984 |
| Decision Date | 10/26/1984 |
| 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
|
|
|