Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K861862 |
Device Name |
DIETO CONTAINER FOR ENTERAL NUTRITION |
Applicant |
GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD. |
79 WEST MONROE ST. |
SUITE 1320 |
CHICAGO,
IL
60603
|
|
Applicant Contact |
ESTHER O KEGAN |
Correspondent |
GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD. |
79 WEST MONROE ST. |
SUITE 1320 |
CHICAGO,
IL
60603
|
|
Correspondent Contact |
ESTHER O KEGAN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/13/1986 |
Decision Date | 08/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|