The following data is part of a premarket notification filed by Nikkiso Co. Ltd. with the FDA for Dbb-06 Hemodialysis Delivery System.
| Device ID | K091978 |
| 510k Number | K091978 |
| Device Name: | DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIKKISO CO. LTD. 4-2-17 HONGO BUNKYO-KU Tokyo, JP 113-0033 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai NIKKISO CO. LTD. 4-2-17 HONGO BUNKYO-KU Tokyo, JP 113-0033 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987671041517 | K091978 | 000 |