| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K960677 |
| Device Name |
KANGAROO JEJUNAL FEEDING SYSTEM |
| Applicant |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Applicant Contact |
CHERYL WINTERS-HEARD, RAC |
| Correspondent |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Correspondent Contact |
CHERYL WINTERS-HEARD, RAC |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 02/16/1996 |
| Decision Date | 05/13/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|