Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K965087 |
Device Name |
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) |
Applicant |
SANDOZ NUTRITION |
P.O. BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Applicant Contact |
ROBERT J LANG |
Correspondent |
SANDOZ NUTRITION |
P.O. BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Correspondent Contact |
ROBERT J LANG |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/19/1996 |
Decision Date | 03/18/1997 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|