Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K081313 |
Device Name |
SH14 HEMOCONCENTRATOR |
Applicant |
SORIN GROUP ITALIA S.R.L. |
200 WEST STREET |
WALTHAM,
MA
02451
|
|
Applicant Contact |
BARRY SALL |
Correspondent |
SORIN GROUP ITALIA S.R.L. |
200 WEST STREET |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
BARRY SALL |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/09/2008 |
Decision Date | 11/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|