Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K212052 |
Device Name |
HMB32 Dialysis Solution |
Applicant |
Haemopharm Biofluids S.r.l. |
Via dell'Industria 6 |
Tovo di S. Agata,
IT
23030
|
|
Applicant Contact |
Francesca Curti |
Correspondent |
Haemopharm Biofluids S.r.l. |
Via dell'Industria 6 |
Tovo di S. Agata,
IT
23030
|
|
Correspondent Contact |
Francesca Curti |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/30/2021 |
Decision Date | 07/23/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|