Device Classification Name |
Pump, Infusion
|
510(k) Number |
K944669 |
Device Name |
FLEXIFLO QUANTUM ENTERAL 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 |
|
Subsequent Product Code |
|
Date Received | 09/13/1994 |
Decision Date | 07/24/1995 |
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
|
|
|