The following data is part of a premarket notification filed by Davita Clinical Research (trri) with the FDA for Dbb-05 Hemodialysis Delivery System.
| Device ID | K023509 |
| 510k Number | K023509 |
| Device Name: | DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | DAVITA CLINICAL RESEARCH (TRRI) 4050 OLSON MEMORIAL HWY Minneapolis, MN 55422 |
| Contact | Tracy L Gray |
| Correspondent | Tracy L Gray DAVITA CLINICAL RESEARCH (TRRI) 4050 OLSON MEMORIAL HWY Minneapolis, MN 55422 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2003-10-30 |
| Summary: | summary |