Device Classification Name |
pump, infusion, enteral
|
510(k) Number |
K940556 |
Device Name |
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP |
Applicant |
SANDOZ NUTRITION |
5320 WEST TWENTY THIRD ST. |
P.O. BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Applicant Contact |
ROBERT J LANG |
Correspondent |
SANDOZ NUTRITION |
5320 WEST TWENTY THIRD ST. |
P.O. BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Correspondent Contact |
ROBERT J LANG |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/07/1994 |
Decision Date | 11/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|