The following data is part of a premarket notification filed by Nikkiso Co. Ltd. with the FDA for Modification To Dbb-05 Hemodialysis Delivery System.
| Device ID | K061519 |
| 510k Number | K061519 |
| Device Name: | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIKKISO CO. LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai NIKKISO CO. LTD. 4-2-1 YUSHIMA BUNKYO-KU Tokyo, JP 113-0034 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2007-09-28 |
| Summary: | summary |