The following data is part of a premarket notification filed by B. Braun Medical Ag with the FDA for Dialog Dialysis Machine.
| Device ID | K963440 |
| 510k Number | K963440 |
| Device Name: | DIALOG DIALYSIS MACHINE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. BRAUN MEDICAL AG 824 12TH AVE. P.O. BOX 4027 Bethlehem, PA 18018 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL AG 824 12TH AVE. P.O. BOX 4027 Bethlehem, PA 18018 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1998-06-26 |
| Summary: | summary |