| Device Classification Name |
Pump, Infusion, Enteral
|
| 510(k) Number |
K952671 |
| Device Name |
RATESAVER PLUS |
| Applicant |
| Entracare Corp. |
| 15731 W. 100th Ter. |
|
Lenexa,
KS
66219
|
|
| Applicant Contact |
AL BOEDEKER |
| Correspondent |
| Entracare Corp. |
| 15731 W. 100th Ter. |
|
Lenexa,
KS
66219
|
|
| Correspondent Contact |
AL BOEDEKER |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 06/12/1995 |
| Decision Date | 08/18/1995 |
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|