Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K192017 |
Device Name |
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate |
Applicant |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
Denise Oppermann |
Correspondent |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Denise Oppermann |
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 07/29/2019 |
Decision Date | 04/24/2020 |
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
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|