The following data is part of a premarket notification filed by Novaflux Technologies with the FDA for Clearflux Dialyzer Reprocessing System.
| Device ID | K091360 |
| 510k Number | K091360 |
| Device Name: | CLEARFLUX DIALYZER REPROCESSING SYSTEM |
| Classification | Dialyzer Reprocessing System |
| Applicant | NOVAFLUX TECHNOLOGIES 1 WALL STREET Princeton, NJ 08540 |
| Contact | Mohamed E Labib |
| Correspondent | Mohamed E Labib NOVAFLUX TECHNOLOGIES 1 WALL STREET Princeton, NJ 08540 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2010-11-03 |
| Summary: | summary |