Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K050827 |
Device Name |
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) |
Applicant |
DIALYSIS SOLUTIONS, INC. |
616 HEATHROW DRIVE |
LINCOLNSHIRE,
IL
60069
|
|
Applicant Contact |
MARCY MACDONALD |
Correspondent |
DIALYSIS SOLUTIONS, INC. |
616 HEATHROW DRIVE |
LINCOLNSHIRE,
IL
60069
|
|
Correspondent Contact |
MARCY MACDONALD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/01/2005 |
Decision Date | 08/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|