Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K233950 |
Device Name |
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) |
Applicant |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
Timothy Groves |
Correspondent |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Timothy Groves |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 12/14/2023 |
Decision Date | 05/10/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|