The following data is part of a premarket notification filed by Nephros, Inc. with the FDA for Olpur Dialyzer, Model Hd 190.
| Device ID | K050603 |
| 510k Number | K050603 |
| Device Name: | OLPUR DIALYZER, MODEL HD 190 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NEPHROS, INC. 3960 BROADWAY New York, NY 10032 |
| Contact | Nadia C Greenidge |
| Correspondent | Nadia C Greenidge NEPHROS, INC. 3960 BROADWAY New York, NY 10032 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-09 |
| Decision Date | 2005-06-09 |
| Summary: | summary |