The following data is part of a premarket notification filed by B. Braun Medizintechnologie Gmbh with the FDA for Diacap Ultra Dialysis Fluid Filter.
| Device ID | K052764 |
| 510k Number | K052764 |
| Device Name: | DIACAP ULTRA DIALYSIS FLUID FILTER |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | B. BRAUN MEDIZINTECHNOLOGIE GMBH SCHWARZENBERGER WEG 73-79 Melsungen, DE D-34212 |
| Contact | Scott J Pease |
| Correspondent | Scott J Pease B. BRAUN MEDIZINTECHNOLOGIE GMBH SCHWARZENBERGER WEG 73-79 Melsungen, DE D-34212 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2006-06-09 |
| Summary: | summary |