The following data is part of a premarket notification filed by Haemopharm Biofluids Srl with the FDA for Hmb32.
| Device ID | K150966 |
| 510k Number | K150966 |
| Device Name: | HMB32 |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | HAEMOPHARM BIOFLUIDS SRL VIA DELL'INDUSTRIA 6 Tovo S. Agata, IT 23030 |
| Contact | Giuseppe Tomasini |
| Correspondent | Shelia Hemeon-heyer HEYER REGULATORY SOLUTIONS LLC P.O. BOX 2151 Amherst, MA 01004 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2015-12-04 |
| Summary: | summary |