Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K903835 |
Device Name |
ACETATE-FREE DIALYSLATE SOLUTION |
Applicant |
PHYSIO, INC. |
53 BISHOPS DR. |
ASTON,
PA
19014
|
|
Applicant Contact |
EUGENE A ELLIS |
Correspondent |
PHYSIO, INC. |
53 BISHOPS DR. |
ASTON,
PA
19014
|
|
Correspondent Contact |
EUGENE A ELLIS |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/21/1990 |
Decision Date | 07/05/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|