The following data is part of a premarket notification filed by B. Braun Avitum Ag with the FDA for Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811.
| Device ID | K100334 |
| 510k Number | K100334 |
| Device Name: | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. BRAUN AVITUM AG 901 MARCON BOULEVARD Allentown, PA 18109 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella B. BRAUN AVITUM AG 901 MARCON BOULEVARD Allentown, PA 18109 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2010-04-22 |
| Summary: | summary |