The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Primus Hollow Fiber Dialyzer (models 1000,1000s,1350,1350s,2000,2000s).
| Device ID | K970648 |
| 510k Number | K970648 |
| Device Name: | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) |
| Classification | Hemodialyzer, Re-use, High Flux |
| Applicant | RENAL SYSTEMS, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Contact | Lynn M Lueders |
| Correspondent | Lynn M Lueders RENAL SYSTEMS, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55447 |
| Product Code | MSF |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1998-01-05 |