The following data is part of a premarket notification filed by Nikkiso Co. Ltd. with the FDA for Nikkiso Co, Ltd., Flx10gw, 12gw, 15gw, 18gw & 21gw Hemodialyzers.
| Device ID | K953996 |
| 510k Number | K953996 |
| Device Name: | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIKKISO CO. LTD. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Contact | Jeffery R Shiderman |
| Correspondent | Jeffery R Shiderman NIKKISO CO. LTD. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-24 |
| Decision Date | 1997-03-19 |