Device Classification Name |
Pump, Infusion, Enteral
|
510(k) Number |
K031407 |
Device Name |
ROSS EMBRACE ENTERAL PUMP |
Applicant |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215 -1724
|
|
Applicant Contact |
DANIEL HAMILTON |
Correspondent |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
625 CLEVELAND AVE. |
COLUMBUS,
OH
43215 -1724
|
|
Correspondent Contact |
DANIEL HAMILTON |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/05/2003 |
Decision Date | 05/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|