Device Classification Name |
pump, infusion, enteral
|
510(k) Number |
K060316 |
Device Name |
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS |
Applicant |
FRESENIUS KABI DEUTSCHLAND GMBH |
DAIMLERSTRASSE 22 |
BAD HOMBURG,
DE
D-61352
|
|
Applicant Contact |
BARBARA BREUER-THAL |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/08/2006 |
Decision Date | 06/23/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|