The following data is part of a premarket notification filed by Haemopharm Biofluids S.r.l. with the FDA for Hmb32 Dialysis Solution.
| Device ID | K212052 |
| 510k Number | K212052 |
| Device Name: | HMB32 Dialysis Solution |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Haemopharm Biofluids S.r.l. Via Dell'Industria 6 Tovo Di S. Agata, IT 23030 |
| Contact | Francesca Curti |
| Correspondent | Francesca Curti Haemopharm Biofluids S.r.l. Via Dell'Industria 6 Tovo Di S. Agata, IT 23030 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-07-23 |