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 | K152938 |
| 510k Number | K152938 |
| Device Name: | DBB-06 Hemodialysis Delivery System |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIKKISO, CO.,LTD. 20-3, EBISU 4-CHOME Shibuya-ku, JP 150-6022 |
| Contact | Seiya Raijyu |
| Correspondent | Fumiaki Kanai MIC INTERNATIONAL 4-1-17 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 | 2015-10-05 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987671060006 | K152938 | 000 |