Device Classification Name |
Tube, Feeding
|
510(k) Number |
K954218 |
Device Name |
STERILE FEEDING TUBE |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
MARY ELLEN SNYDER |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
MARY ELLEN SNYDER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/08/1995 |
Decision Date | 11/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|