The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Nephros Olpur H2h Hemodiafiltration (hdf) Module And Olpur Md 220 Hemodiafilter.
| Device ID | K112314 |
| 510k Number | K112314 |
| Device Name: | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
| Contact | Greg Collins |
| Correspondent | Greg Collins NEPHROS, INC. 41 GRAND AVE. River Edge, NJ 07661 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10896241002364 | K112314 | 000 |
| 10896241002081 | K112314 | 000 |
| 10896241002074 | K112314 | 000 |
| 10896241002067 | K112314 | 000 |
| 20896241002057 | K112314 | 000 |