The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Fb-u Hemodialyzer.
| Device ID | K160444 |
| 510k Number | K160444 |
| Device Name: | FB-U Hemodialyzer |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. Doral, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. Doral, FL 33172 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2017-02-08 |
| Summary: | summary |