| Device Classification Name |
Tube, Feeding
|
| 510(k) Number |
K895824 |
| Device Name |
L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET |
| Applicant |
| Intl. Medical Marketing, Inc. |
| P.O. Box 578 |
|
Ridge,
NY
11961
|
|
| Applicant Contact |
RAMON MONAST |
| Correspondent |
| Intl. Medical Marketing, Inc. |
| P.O. Box 578 |
|
Ridge,
NY
11961
|
|
| Correspondent Contact |
RAMON MONAST |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 09/29/1989 |
| Decision Date | 03/13/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|