Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K171015 |
Device Name |
Citryte |
Applicant |
Di-Chem, Inc. |
12297 Ensign Avenue North |
Champlin,
MN
55316
|
|
Applicant Contact |
Keith Buchholz |
Correspondent |
Di-Chem, Inc. |
12297 Ensign Avenue North |
Champlin,
MN
55316
|
|
Correspondent Contact |
Keith Buchholz |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/04/2017 |
Decision Date | 10/13/2017 |
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
|
|
|