Device Classification Name |
pump, infusion, enteral
|
510(k) Number |
K943733 |
Device Name |
FLEXIFLO SIX ENTERAL NUTRITION PUMP |
Applicant |
ABBOTT MFG., INC. |
1033 KINGSMILL PKWY. |
COLUMBUS,
OH
43229
|
|
Applicant Contact |
MICHAEL H HANEY |
Correspondent |
ABBOTT MFG., INC. |
1033 KINGSMILL PKWY. |
COLUMBUS,
OH
43229
|
|
Correspondent Contact |
MICHAEL H HANEY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/02/1994 |
Decision Date | 12/12/1994 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|