Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K000724 |
Device Name |
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 |
Applicant |
MEDICA S.R.L. |
100 MAIN ST. |
SUITE 120 |
CONCORD,
MA
01742
|
|
Applicant Contact |
JAMES DELANEY |
Correspondent |
MEDICA S.R.L. |
100 MAIN ST. |
SUITE 120 |
CONCORD,
MA
01742
|
|
Correspondent Contact |
JAMES DELANEY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/06/2000 |
Decision Date | 03/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|